Two-piece ostomy bag – Only drainable bag (Velcro type)

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A Two-piece ostomy bag – Only drainable bag (Velcro type) is a single-use, drainable ostomy pouch with a Velcro (hook-and-loop) closure mechanism, designed to be attached to a two-piece ostomy baseplate (skin barrier/flange) for the collection and management of liquid or semi-formed stool in patients with an ileostomy or colostomy who have high-output, pasty, or liquid stools .

The pouch features a mechanical coupling (flex coupling or guided coupling) with an audible “click” that confirms secure locking, and a floating ring/flange that allows attachment without applying pressure to the abdomen near the stoma . The integrated Velcro closure (hook-and-loop fastener) provides a simple, intuitive, and highly reliable way to seal the drainable outlet after emptying. Unlike plastic clamps, the Velcro closure has no loose parts that can be dropped or lost, and it is easier for patients with arthritis or reduced manual dexterity to operate .

Constructed with multi-layer, 100% odor-proof film and covered with a soft, breathable non-woven fabric (ComfortWear™ panels), the pouch includes an integrated activated charcoal filter (standard or full-circle) that allows flatus to escape while containing odor, preventing “ballooning” that can be visible under clothing . High-output models are available with up to 980mL capacity and can be connected to overnight drainage bags for uninterrupted sleep .

For the stoma care nurse and colorectal surgeon, the two-piece Velcro-type drainable system is indicated for ileostomates (who typically require drainable pouches due to liquid output) and select colostomates with semi-formed or liquid stool . The baseplate remains in place for 2-7 days while the Velcro-type drainable pouch is emptied multiple times daily and changed every 1-3 days, reducing skin trauma from repeated full appliance changes and lowering supply costs .

For the patient with an ileostomy or high-output colostomy, the two-piece Velcro-type drainable pouch provides security, confidence, and the freedom to participate fully in daily activities—including work, travel, sports, and swimming—without fear of leakage or odor. The simple, quiet, arthritis-friendly Velcro closure makes this system particularly well-suited for patients with reduced hand strength or dexterity, as well as those who prefer a hassle-free, reliable closure mechanism. The ability to empty the pouch multiple times without removing the baseplate significantly improves quality of life and reduces the painful complications of peristomal skin breakdown.

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Categories: CONSUMABLES AND DISPOSABLES, Incontinence Products, Wound Care Tags: ConvaTec Esteem drainable, drainable ileostomy pouch Velcro, Hollister New Image drainable pouch, ileostomy bag drainable hook-and-loop, New Image drainable Velcro, open-ended ostomy bag Velcro, SenSura Mio Click drainable, Two-piece drainable ostomy bag, two-piece drainable pouch with Velcro, two-piece Velcro drainable bag, Velcro closure ostomy pouch

Description

Two-piece ostomy bag – Only drainable bag (Velcro type)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Collection and Management of Liquid to Semi-Formed Stool Following Ileostomy or Colostomy Surgery

Primary Use: Provides a single-use, drainable ostomy pouch with a Velcro (hook-and-loop) closure mechanism, designed to be attached to a two-piece ostomy baseplate (skin barrier/flange) for the collection and management of liquid or semi-formed stool in patients with an ileostomy or colostomy who have high-output, pasty, or liquid stools .
How it helps: For the stoma care nurse and colorectal surgeon, the Velcro-type drainable two-piece pouch is indicated for patients with an ileostomy (where stool is liquid or pasty) and for colostomates with semi-formed or liquid output who require frequent emptying rather than full pouch changes . The Velcro closure allows the patient to empty the pouch through its openable bottom outlet without removing the entire appliance from the baseplate. For the patient with high-output liquid stool, the Velcro-type drainable pouch offers a simple, intuitive, and highly reliable closure that can be opened and resealed 4-6 times daily with a quick wipe-down, significantly reducing skin trauma, lowering supply costs, and enabling more normal daily routines. The soft fabric of the Velcro closure is comfortable against the skin and produces minimal noise.

2. Two-Piece System Benefit: Pouch Changes Without Baseplate Removal

Primary Use: The two-piece design allows the Velcro-type drainable pouch to be detached from the baseplate and replaced with a new pouch while the baseplate remains securely adhered to the peristomal skin .
How it helps: For the clinician and patient, this is the key advantage of a two-piece system. The baseplate can remain in place for 2-3 days (or up to 7 days with extended wear products), while the Velcro-type drainable pouch is emptied multiple times daily and replaced every 1-3 days . This reduces skin trauma from repeated full appliance changes, lowers overall supply costs, and minimizes disruption to the patient’s routine. For the patient with an ileostomy, the ability to empty the pouch 4-6 times daily without removing the baseplate significantly reduces skin irritation, lowers supply costs, and enables more normal daily routines with fewer disruptions.

3. Secure Mechanical Coupling with Audible Lock Confirmation

Primary Use: Features a mechanical coupling system (flex coupling or guided coupling) that securely attaches the Velcro-type drainable pouch to the matching convex or flat baseplate flange. The coupling has a floating ring design that allows the pouch to be pressed onto the baseplate without applying direct pressure to the abdomen near the stoma .
How it helps: For the patient, the mechanical coupling provides a secure, leak-proof connection that can be trusted during daily activities, including work, exercise, and sleep. The audible “click” confirms that the pouch is properly locked in position, eliminating guesswork and providing peace of mind . The floating flange design prevents discomfort during pouch attachment by distributing pressure away from the sensitive peristomal area, allowing fingers to be placed under the flange to minimise abdominal pressure during attachment .

4. Velcro Closure Mechanism for Easy, Silent, and Reliable Emptying

Primary Use: Features an open-ended bottom outlet with a Velcro (hook-and-loop) closure mechanism that is easy to open, clean, and reseal. The Velcro closure is designed to be simple to use, produces minimal noise, and creates a secure seal when pressed firmly. The closure is typically integrated into the pouch design, with no small parts that could be lost (unlike plastic clamps) .
How it helps: For the patient, the Velcro closure is intuitive and easy to operate—simply press to seal, pull to open. It requires no instruction to use and eliminates the risk of losing small parts (as can happen with plastic clamps). The Velcro closure is also quieter than other closure types, which is particularly important for discretion in public restrooms or quiet environments . The wide opening allows for easy cleaning, and the secure seal prevents leakage when properly closed. For patients with arthritis or reduced manual dexterity, the Velcro closure is easier to manage than plastic clamps or soft taps .

SECONDARY & SUPPORTIVE USES

1. High-Output Stoma Management (Up to 980mL Capacity): Designed for patients with high-output ileostomies; some models feature extra-large capacity pouches (up to 980mL) for post-operative use and for high-output stoma management . Can be connected to overnight drainage bags for uninterrupted sleep .

2. Integration with Night Drainage Systems: Compatible with drainable pouches that can be connected to overnight drainage bags, allowing patients with high-output ileostomies to sleep uninterrupted while the system manages continuous drainage .

3. Integration with Flat or Convex Baseplates: The Velcro-type drainable pouch is compatible with both flat baseplates (for normal peristomal profiles) and convex baseplates (for flush or retracted stomas), allowing the same pouch type to be used across different patient anatomies .

4. Opaque and Transparent Options: Available in opaque grey or beige for discretion, or transparent with measuring scale for clinical assessment in the post-operative period, allowing clinicians to inspect stoma health and output without removing the appliance .

5. Full-Circle Filter Technology for Ballooning Reduction: Some systems feature a full-circle filter that reduces ballooning (pouch distention from gas) by up to 61%, improving discretion and helping patients sleep better at night .

6. Soft Fabric Backing for Comfort: Features a soft, breathable, double-sided non-woven fabric covering the body-facing side (ComfortWear™ panels) to reduce friction, noise (rustling), and moisture against the skin; available in beige, neutral grey, or white .

7. Ostomy Belt Compatibility: Many Velcro-type drainable pouches are compatible with ostomy belts that clip onto the baseplate, providing additional security during physical activities. Belt tabs are integrated into the coupling ring .

8. Manufacturer System Compatibility: The Velcro-type drainable pouch is designed to work with the baseplate of the same manufacturer system (e.g., Coloplast SenSura Mio, Hollister New Image, ConvaTec Esteem). It is not interchangeable between different brands .

9. Transparent with Measuring Scale for Clinical Assessment: Some models feature transparent film with a measuring scale to help estimate output amount, essential for post-operative monitoring of high-output stomas .

10. Easy-to-Clean Wide Outlet: The Velcro closure typically features a wide outlet design that is easier to clean and less prone to clogging compared to narrower closures .

11. No Loose Parts Design: Unlike plastic clamps that can be dropped or lost, the Velcro closure is integrated into the pouch, eliminating the risk of losing small parts during emptying .

12. Arthritis-Friendly Design: The Velcro closure is easier for patients with arthritis, reduced hand strength, or poor manual dexterity to operate compared to plastic clamps or soft silicone taps .

13. Low-Profile Design for Active Lifestyles: The Velcro-type drainable pouch is designed to be low-profile, flat, and discreet under clothing, with soft, breathable non-woven fabric backing that reduces friction and noise (rustling) during movement—essential for physically active patients .

14. High-Output Post-Operative Use: Specifically designed for post-operative use where stoma output is higher and more liquid; the Velcro drainable design allows for frequent emptying without removing the appliance .

15. Sound-Absorbing Material for Discretion: Quiet material that does not rustle during movement, with sound-absorbing fabric for discretion; the Velcro closure itself is quieter than plastic clamps .

16. Elastic Adhesive Compatibility: When used with compatible elastic adhesive baseplates, the system follows natural body movements, improving wear time and comfort .

17. Washable Fabric Outer Layer: Some Velcro-type drainable pouches feature micro-perforated material on the skin side that is washable, allowing for extended use and improved hygiene .

18. Deodorizing Technology: Some pouches feature integrated deodorizing technology to eliminate unpleasant odours, providing an additional layer of odor containment beyond the charcoal filter .

KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A single-use, drainable ostomy pouch with a Velcro (hook-and-loop) closure mechanism, designed to be attached to a two-piece ostomy baseplate for the collection and management of liquid or semi-formed stool in patients with an ileostomy or colostomy. It is part of a two-piece system where the pouch is exchanged without removing the baseplate .
Designation: Two-piece drainable ostomy bag, Velcro closure drainable pouch, two-piece drainable pouch with Velcro, ileostomy pouch drainable Velcro, open-ended ostomy bag, two-piece Velcro drainable bag .
Key Components:

Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH - Ethylene-Vinyl Alcohol Copolymer) designed for liquid to pasty stool .
Mechanical Coupling (Flange Ring): A plastic ring (flex coupling or guided coupling) that snaps onto the matching ring on the baseplate, providing a secure, audible lock .
Floating Ring/Floating Flange: Allows the pouch to be attached and removed without applying pressure to the abdomen near the stoma; fingers can be placed under the flange to minimise abdominal pressure .
Drainable Outlet: An open-ended tail at the bottom of the pouch for emptying liquid or pasty stool .
Velcro Closure (Hook-and-Loop): A resealable fabric fastener closure system that seals the outlet after emptying; integrated into the pouch (no loose parts) .
Filter: An integrated activated charcoal filter (standard or full-circle) to allow flatus to escape while containing odor, preventing ballooning .
Comfort Layer: A soft, breathable double-sided non-woven fabric covering the body-facing side to reduce friction, noise, and moisture against the skin (ComfortWear™ panels) .
Belt Tabs: Integrated tabs on the coupling ring for attaching an ostomy belt for additional security .
Velcro Closure Features: Wide opening, easy to clean, no loose parts, quiet operation, arthritis-friendly .

2. TECHNICAL & PERFORMANCE PROPERTIES

GMDN Term & Definition: Two-piece ostomy bag. A device designed to be attached to a base plate as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a pasty consistency). The device consists of a pouch designed to be attached, via a flange, to a base plate. The proximal end of the device is open to the stoma and the distal end is openable for drainage (drainable). Typically, it is intended to be replaced one to three times per day .
FDA Product Code: EZS - Ostomy Pouch .
Capacity: Standard drainable pouch capacity ranges from 500 mL to 980 mL depending on size and manufacturer. High-output models available up to 980 mL .
Coupling Type: Mechanical (flex coupling or guided coupling) with audible click confirmation; floating flange for pressure-free attachment; available with different coupling sizes (typically 50mm, 55mm, 60mm, 70mm) .
Drainable Outlet Type: Open-ended / drainable with Velcro (hook-and-loop) closure .
Velcro Closure Mechanism: Integrated hook-and-loop fabric fastener .

Operation: Press firmly to seal; pull apart to open .
Advantages: No loose parts, arthritis-friendly, quiet operation, wide opening for easy cleaning .

Filter Type: Activated charcoal filter; available as standard filter or full-circle filter that reduces ballooning by up to 61% .
Body-side Covering: Soft double-sided non-woven fabric that is quiet, breathable, non-rustling; available in opaque (beige, neutral grey, white) for discretion .
Belt Fixation: Belt tabs integrated into coupling ring; available in two or three different positions .
Wear Time (Pouch): The Velcro-type drainable pouch is emptied multiple times daily and typically changed every 1-3 days. The baseplate remains in place for 2-7 days while pouches are exchanged .
Wear Time (Baseplate): 2-7 days depending on product line and patient anatomy .
Sterility: Non-sterile; intended for use on clean, intact peristomal skin with a properly adhered baseplate .
Single-Use: Intended for single patient use only; the pouch is emptied multiple times but discarded when soiled or after recommended wear time .
Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .
Product Characteristics: Drainable, odour-proof, non-sterile, single-use, Velcro closure, no loose parts .
Packaging: Individually wrapped; sold in boxes (e.g., 10, 20, 30 pieces) .

3. PHYSICAL & OPERATIONAL PROPERTIES

Configuration: Part of a two-piece system where the Velcro-type drainable pouch and baseplate are separate components attached via a mechanical coupling; the drainable pouch is emptied multiple times and exchanged while the baseplate remains on the skin .
Appearance: Available in opaque (fabric-covered) for discretion (beige, neutral grey), or transparent/translucent with measuring scale for clinical assessment .
Flexibility: Flexible pouch design that conforms to body movement; soft coupling material for adaptability to body contours .
Coupling Orientation: Systems may offer multiple coupling positions for optimal pouch orientation .
Velcro Closure Characteristics:

Simplicity: Intuitive to use with no training required
Noise Level: Quieter than plastic clamps
Security: Creates a secure seal when pressed firmly
Maintenance: Easy to clean with a damp cloth after emptying
Durability: Reliable for multiple emptying cycles per day

Wear Time (Pouch): The drainable pouch is emptied multiple times daily and typically changed every 1-3 days. The baseplate remains in place for 2-7 days while pouches are exchanged .
Output Assessment: Transparent measuring scale allows estimation of output amount; viewing window allows stoma inspection without pouch removal .
Noise Reduction: Quiet material that does not rustle during movement, with sound-absorbing fabric for discretion; Velcro closure itself is quieter than plastic clamp alternatives .
Odor Control: Multi-layer film provides 100% odor-proof barrier; activated charcoal filter deodorizes escaping gas; some pouches feature integrated deodorizing technology .
Application: Attach to the coupling ring of the baseplate, press until audible click confirms secure locking. The floating ring allows attachment without abdominal pressure .
Emptying Procedure:

Open the Velcro closure by pulling apart .
Empty contents into the toilet .
Wipe the outlet clean with toilet paper or a damp cloth .
Press the Velcro closure firmly to reseal .
Wash hands thoroughly .

Pouch Removal (Discarding): Press the release tabs on the coupling ring to detach the pouch. The baseplate remains adhered to the skin. Dispose of the used pouch in general waste .

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class I medical device (FDA Product Code EZS - Ostomy Pouch) .
Quality Standards: Complies with international ostomy standards; manufactured under quality management systems (ISO 13485). CE marked for European market .
Biocompatibility: Manufactured with skin-friendly, hypoallergenic, non-irritating materials; hydrocolloid-free (the pouch itself does not contact the skin; the baseplate provides skin adhesion) .
Odor Control: Certified to meet odor-barrier efficacy standards using multilayer high-barrier co-extrusion membrane .
Latex-Free: Manufactured without natural rubber latex .
Velcro Closure Safety: Integrated design eliminates risk of lost parts (unlike plastic clamps); no small parts that could be a choking hazard .
Storage: Store in a cool, dry place away from direct heat and sunlight, which can degrade the materials and the Velcro closure .
Expiration: Shelf life typically 3 years; check packaging for expiration date .

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store in a cool, dry place at room temperature below 30°C (86°F). Avoid exposure to direct sunlight, extreme heat, or humidity, which can degrade the pouch film, filter, and Velcro closure materials. Keep out of reach of children .
Shelf Life: Typically 3 years from the date of manufacture when stored properly; check individual packaging for expiration date .
Pre-use Preparation: No special preparation required before attaching to the baseplate .
Coupling Check: Ensure the coupling ring is clean and dry before attaching to the baseplate; if stool contacts the coupling ring, it should be cleaned before attaching a new pouch .
Pouch Attachment: Align the coupling ring with the baseplate flange and press together firmly until an audible "click" confirms secure locking. The floating ring allows attachment without abdominal pressure .
Velcro Closure Care: After emptying, wipe the outlet clean with toilet paper or a damp cloth. Ensure the Velcro closure is dry before resealing. Press firmly along the entire closure to ensure a secure seal .
Pouch Removal (Emptying):

Open the Velcro closure by gently pulling apart .
Empty contents into the toilet .
Wipe the outlet clean .
Press the Velcro closure firmly to reseal .

Pouch Removal (Discarding): Press the release tabs on the coupling ring to detach the used pouch. The baseplate remains adhered to the skin. Dispose of the used pouch in general waste per local regulations. Do not flush .
Output Monitoring: Use the transparent measuring scale (if available) or viewing window to assess stool volume and consistency without removing the pouch .
Filter Care: When showering or swimming, use the provided filter cover sticker (if available) to prevent water from entering the filter and saturating the pouch .

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Collection and management of liquid or semi-formed stool following ileostomy or colostomy surgery in patients with high-output, pasty, or liquid stools. The Velcro-type drainable pouch is part of a two-piece system where pouches are emptied multiple times daily and exchanged without removing the baseplate .
Clinical Role: Essential post-operative and long-term care device in colorectal surgery, gastroenterology, and home healthcare for the management of patients with an ileostomy or colostomy who have high-output or liquid stool requiring frequent emptying. Particularly beneficial for patients with arthritis, reduced manual dexterity, or those who prefer a simple, intuitive closure mechanism .

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Indication for Use: The Velcro-type drainable two-piece pouch is indicated for patients with an ileostomy who have liquid or pasty stool, and for colostomates with semi-formed or liquid output. For patients with formed stool who only need to change the pouch 1-2 times daily, a closed pouch may be more appropriate .
Compatibility: The Velcro-type drainable pouch must be used with a compatible baseplate from the same manufacturer system. Pouches and baseplates from different manufacturers are not interchangeable .
Contraindications: Do not use on patients with known hypersensitivity to pouch materials (polyethylene, EVOH, adhesives on the baseplate). For patients with very thick, formed stool, a closed pouch may be more appropriate.
Velcro Closure Security: Ensure the Velcro closure is pressed firmly along its entire length after each emptying. An improperly sealed closure may cause leakage . Inspect the closure for wear or damage before each use .
Coupling Security: Ensure the pouch is properly locked onto the baseplate before resuming activity. The audible "click" confirms secure locking. A pouch that is not properly attached may detach, causing leakage .
Monitor for Leaks: Inspect the pouch and baseplate seal frequently. Change the pouch immediately if any effluent is observed leaking from the coupling, the Velcro closure, or under the baseplate .
Output Volume Monitoring: For patients with higher than expected output, ensure the pouch is emptied before it becomes overfull. For high-output stomas, consider a high-output pouch (up to 980mL capacity) .
Filter Management: When showering or swimming, use the provided filter cover sticker (if available) to prevent water from entering the filter and saturating the pouch .
Skin Assessment: At each baseplate change (every 2-7 days), assess the peristomal skin for signs of irritation, maceration, or infection. The two-piece design allows pouch changes without disturbing the baseplate, reducing skin trauma .
Velcro Closure Wear: Over time (multiple uses), the Velcro closure may accumulate debris or lose its gripping strength. Replace the pouch if the closure does not seal securely .
Do Not Reuse: This is a single-use device; do not attempt to wash, resterilize, or reapply a used drainable pouch .

2. FIRST AID MEASURES

Adhesive Reaction (Baseplate): If signs of an allergic reaction to the baseplate adhesive (rash, severe itching, blistering) occur, remove the entire appliance (baseplate and pouch), gently cleanse the skin with mild soap and water, discontinue use of that product line, and consult a clinician.
Leakage: If a leak occurs, remove the pouch and baseplate immediately, gently cleanse the skin with warm water, dry thoroughly, and apply a new baseplate and pouch. If leakage recurs, consult a stoma care nurse to reassess stoma size and convexity needs .
Bleeding Stoma: If the stoma bleeds when cleaning (common due to high vascularity), apply gentle pressure with a clean, dry gauze pad for a few minutes. Contact a clinician if bleeding is profuse or does not stop.
Coupling Failure: If the mechanical coupling does not produce an audible "click" or feels loose, do not use the pouch. Discard it and use a new pouch from the same manufacturer lot. If coupling failure persists, contact the manufacturer.
Velcro Closure Failure: If the Velcro closure fails to seal securely (e.g., does not stay closed, does not make a firm seal), discard the pouch and replace it with a new one. Inspect the closure for debris or wear before discarding.

3. FIRE FIGHTING MEASURES

Flammability: The plastic pouch, non-woven fabric, and Velcro closure are combustible. Keep away from open flames and direct heat sources.
Extinguishing Media: Use water, foam, CO₂, or dry chemical for fires involving combustible material. The pouch presents no special fire hazard beyond typical medical plastics.
Storage Warning: Do not store ostomy supplies near radiators, heating vents, or in vehicles during hot weather, as extreme heat can degrade the plastic film, filter, and Velcro closure materials.

Two-piece ostomy bag – Only drainable bag (Velcro type)

Two-piece ostomy bag – Only drainable bag (Velcro type)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Collection and Management of Liquid to Semi-Formed Stool Following Ileostomy or Colostomy Surgery

2. Two-Piece System Benefit: Pouch Changes Without Baseplate Removal

Primary Use: The two-piece design allows the Velcro-type drainable pouch to be detached from the baseplate and replaced with a new pouch while the baseplate remains securely adhered to the peristomal skin .

3. Secure Mechanical Coupling with Audible Lock Confirmation

4. Velcro Closure Mechanism for Easy, Silent, and Reliable Emptying

SECONDARY & SUPPORTIVE USES

2. Integration with Night Drainage Systems: Compatible with drainable pouches that can be connected to overnight drainage bags, allowing patients with high-output ileostomies to sleep uninterrupted while the system manages continuous drainage .

3. Integration with Flat or Convex Baseplates: The Velcro-type drainable pouch is compatible with both flat baseplates (for normal peristomal profiles) and convex baseplates (for flush or retracted stomas), allowing the same pouch type to be used across different patient anatomies .

4. Opaque and Transparent Options: Available in opaque grey or beige for discretion, or transparent with measuring scale for clinical assessment in the post-operative period, allowing clinicians to inspect stoma health and output without removing the appliance .

5. Full-Circle Filter Technology for Ballooning Reduction: Some systems feature a full-circle filter that reduces ballooning (pouch distention from gas) by up to 61%, improving discretion and helping patients sleep better at night .

6. Soft Fabric Backing for Comfort: Features a soft, breathable, double-sided non-woven fabric covering the body-facing side (ComfortWear™ panels) to reduce friction, noise (rustling), and moisture against the skin; available in beige, neutral grey, or white .

7. Ostomy Belt Compatibility: Many Velcro-type drainable pouches are compatible with ostomy belts that clip onto the baseplate, providing additional security during physical activities. Belt tabs are integrated into the coupling ring .

8. Manufacturer System Compatibility: The Velcro-type drainable pouch is designed to work with the baseplate of the same manufacturer system (e.g., Coloplast SenSura Mio, Hollister New Image, ConvaTec Esteem). It is not interchangeable between different brands .

9. Transparent with Measuring Scale for Clinical Assessment: Some models feature transparent film with a measuring scale to help estimate output amount, essential for post-operative monitoring of high-output stomas .

10. Easy-to-Clean Wide Outlet: The Velcro closure typically features a wide outlet design that is easier to clean and less prone to clogging compared to narrower closures .

11. No Loose Parts Design: Unlike plastic clamps that can be dropped or lost, the Velcro closure is integrated into the pouch, eliminating the risk of losing small parts during emptying .

12. Arthritis-Friendly Design: The Velcro closure is easier for patients with arthritis, reduced hand strength, or poor manual dexterity to operate compared to plastic clamps or soft silicone taps .

13. Low-Profile Design for Active Lifestyles: The Velcro-type drainable pouch is designed to be low-profile, flat, and discreet under clothing, with soft, breathable non-woven fabric backing that reduces friction and noise (rustling) during movement—essential for physically active patients .

14. High-Output Post-Operative Use: Specifically designed for post-operative use where stoma output is higher and more liquid; the Velcro drainable design allows for frequent emptying without removing the appliance .

15. Sound-Absorbing Material for Discretion: Quiet material that does not rustle during movement, with sound-absorbing fabric for discretion; the Velcro closure itself is quieter than plastic clamps .

16. Elastic Adhesive Compatibility: When used with compatible elastic adhesive baseplates, the system follows natural body movements, improving wear time and comfort .

17. Washable Fabric Outer Layer: Some Velcro-type drainable pouches feature micro-perforated material on the skin side that is washable, allowing for extended use and improved hygiene .

18. Deodorizing Technology: Some pouches feature integrated deodorizing technology to eliminate unpleasant odours, providing an additional layer of odor containment beyond the charcoal filter .

1. BASIC IDENTIFICATION ATTRIBUTES

Designation: Two-piece drainable ostomy bag, Velcro closure drainable pouch, two-piece drainable pouch with Velcro, ileostomy pouch drainable Velcro, open-ended ostomy bag, two-piece Velcro drainable bag .

Key Components:

Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH - Ethylene-Vinyl Alcohol Copolymer) designed for liquid to pasty stool .

Mechanical Coupling (Flange Ring): A plastic ring (flex coupling or guided coupling) that snaps onto the matching ring on the baseplate, providing a secure, audible lock .

Floating Ring/Floating Flange: Allows the pouch to be attached and removed without applying pressure to the abdomen near the stoma; fingers can be placed under the flange to minimise abdominal pressure .

Drainable Outlet: An open-ended tail at the bottom of the pouch for emptying liquid or pasty stool .

Velcro Closure (Hook-and-Loop): A resealable fabric fastener closure system that seals the outlet after emptying; integrated into the pouch (no loose parts) .

Filter: An integrated activated charcoal filter (standard or full-circle) to allow flatus to escape while containing odor, preventing ballooning .

Comfort Layer: A soft, breathable double-sided non-woven fabric covering the body-facing side to reduce friction, noise, and moisture against the skin (ComfortWear™ panels) .

Belt Tabs: Integrated tabs on the coupling ring for attaching an ostomy belt for additional security .

Velcro Closure Features: Wide opening, easy to clean, no loose parts, quiet operation, arthritis-friendly .

2. TECHNICAL & PERFORMANCE PROPERTIES

FDA Product Code: EZS - Ostomy Pouch .

Capacity: Standard drainable pouch capacity ranges from 500 mL to 980 mL depending on size and manufacturer. High-output models available up to 980 mL .

Coupling Type: Mechanical (flex coupling or guided coupling) with audible click confirmation; floating flange for pressure-free attachment; available with different coupling sizes (typically 50mm, 55mm, 60mm, 70mm) .

Drainable Outlet Type: Open-ended / drainable with Velcro (hook-and-loop) closure .

Velcro Closure Mechanism: Integrated hook-and-loop fabric fastener .

Operation: Press firmly to seal; pull apart to open .

Advantages: No loose parts, arthritis-friendly, quiet operation, wide opening for easy cleaning .

Filter Type: Activated charcoal filter; available as standard filter or full-circle filter that reduces ballooning by up to 61% .

Body-side Covering: Soft double-sided non-woven fabric that is quiet, breathable, non-rustling; available in opaque (beige, neutral grey, white) for discretion .

Belt Fixation: Belt tabs integrated into coupling ring; available in two or three different positions .

Wear Time (Pouch): The Velcro-type drainable pouch is emptied multiple times daily and typically changed every 1-3 days. The baseplate remains in place for 2-7 days while pouches are exchanged .

Wear Time (Baseplate): 2-7 days depending on product line and patient anatomy .

Sterility: Non-sterile; intended for use on clean, intact peristomal skin with a properly adhered baseplate .

Single-Use: Intended for single patient use only; the pouch is emptied multiple times but discarded when soiled or after recommended wear time .

Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .

Product Characteristics: Drainable, odour-proof, non-sterile, single-use, Velcro closure, no loose parts .

Packaging: Individually wrapped; sold in boxes (e.g., 10, 20, 30 pieces) .

3. PHYSICAL & OPERATIONAL PROPERTIES

Configuration: Part of a two-piece system where the Velcro-type drainable pouch and baseplate are separate components attached via a mechanical coupling; the drainable pouch is emptied multiple times and exchanged while the baseplate remains on the skin .

Appearance: Available in opaque (fabric-covered) for discretion (beige, neutral grey), or transparent/translucent with measuring scale for clinical assessment .

Flexibility: Flexible pouch design that conforms to body movement; soft coupling material for adaptability to body contours .

Coupling Orientation: Systems may offer multiple coupling positions for optimal pouch orientation .

Velcro Closure Characteristics:

Simplicity: Intuitive to use with no training required

Noise Level: Quieter than plastic clamps

Security: Creates a secure seal when pressed firmly

Maintenance: Easy to clean with a damp cloth after emptying

Durability: Reliable for multiple emptying cycles per day

Wear Time (Pouch): The drainable pouch is emptied multiple times daily and typically changed every 1-3 days. The baseplate remains in place for 2-7 days while pouches are exchanged .

Output Assessment: Transparent measuring scale allows estimation of output amount; viewing window allows stoma inspection without pouch removal .

Noise Reduction: Quiet material that does not rustle during movement, with sound-absorbing fabric for discretion; Velcro closure itself is quieter than plastic clamp alternatives .

Odor Control: Multi-layer film provides 100% odor-proof barrier; activated charcoal filter deodorizes escaping gas; some pouches feature integrated deodorizing technology .

Application: Attach to the coupling ring of the baseplate, press until audible click confirms secure locking. The floating ring allows attachment without abdominal pressure .

Emptying Procedure:

Open the Velcro closure by pulling apart .

Empty contents into the toilet .

Wipe the outlet clean with toilet paper or a damp cloth .

Press the Velcro closure firmly to reseal .

Wash hands thoroughly .

Pouch Removal (Discarding): Press the release tabs on the coupling ring to detach the pouch. The baseplate remains adhered to the skin. Dispose of the used pouch in general waste .

4. SAFETY & COMPLIANCE ATTRIBUTES