Two-piece ostomy bag – Only closed bag

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A Two-piece ostomy bag – Only closed bag is a single-use, closed-end ostomy pouch designed to be attached to a two-piece ostomy baseplate (skin barrier/flange) for the collection of formed or semi-formed stool in patients with a colostomy . The closed pouch is part of a two-piece system where the pouch is changed without removing the baseplate, which remains adhered to the peristomal skin for 2-3 days .

The pouch features a mechanical coupling (flex coupling or guided coupling) with an audible “click” that confirms secure locking, and a floating ring that allows attachment without applying pressure to the abdomen near the stoma . The closed design is intended for single-use disposal; when full, the entire pouch is removed and discarded, and a new pouch is attached to the existing baseplate .

Constructed with multi-layer, 100% odor-proof film and covered with a soft, breathable non-woven fabric, the pouch includes an integrated activated charcoal filter (full-circle filter options available) that allows flatus to escape while containing odor, preventing “ballooning” that can be visible under clothing . A transparent viewing window allows output assessment without removing the pouch, while the opaque fabric cover provides discretion .

For the stoma care nurse and colorectal surgeon, the two-piece closed system is indicated for colostomates with predictable, regular bowel movements who produce formed stool. The baseplate remains in place while pouches are changed as needed (typically 1-2 times daily), reducing skin trauma from repeated full appliance changes . The closed design offers the ultimate convenience and hygiene—no need to empty or clean the pouch .

For the patient with a colostomy, the two-piece closed 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 ability to change pouches quickly without removing the baseplate makes this system particularly well-suited for active lifestyles and travel, where access to a toilet for emptying a drainable pouch may be limited.

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Categories: CONSUMABLES AND DISPOSABLES, Incontinence Products, Wound Care Tags: closed-end colostomy pouch, colostomy pouch closed, Esteem Symphony closed pouch, New Image two-piece closed, non-drainable ostomy bag, SenSura Mio Click Close, Two-piece closed ostomy bag, two-piece closed pouch, two-piece ostomy appliance closed

Description

Two-piece ostomy bag – Only closed bag

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Collection of Formed or Semi-Formed Stool Following Colostomy Surgery

Primary Use: Provides a single-use, closed-end ostomy pouch designed to be attached to a two-piece ostomy baseplate (skin barrier/flange) for the collection of formed or semi-formed stool in patients with a colostomy .
How it helps: For the stoma care nurse and colorectal surgeon, the closed two-piece pouch is indicated for patients with predictable, regular bowel movements who produce formed stool—typically following colostomy. The closed design is intended for single-use disposal; when the pouch is full, the entire unit is removed and discarded, and a new pouch is attached to the existing baseplate . For the patient with a colostomy, the closed pouch offers the ultimate convenience and hygiene, as there is no need to empty or clean the pouch—simply remove, discard, and replace with a fresh pouch.

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

Primary Use: The two-piece design allows the closed 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, while the closed pouch is changed as needed (typically 1-2 times daily for colostomates with formed stool). This reduces skin trauma from repeated full appliance changes, lowers overall supply costs, and minimizes disruption to the patient’s routine . For the patient, the ability to change pouches without stripping the adhesive from the skin each time significantly reduces the risk of Medical Adhesive-Related Skin Injury (MARSI) and allows for quick, hygienic changes even in public restrooms.

3. Secure Mechanical Coupling with Audible Lock Confirmation

Primary Use: Features a mechanical coupling system (flex coupling or guided coupling) that securely attaches the closed 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.

4. Odor Control and Gas Management

Primary Use: The closed pouch is constructed with multi-layer, 100% odor-proof film and features an integrated activated charcoal filter that allows flatus (gas) to escape while trapping odor molecules, preventing “ballooning” (pouch distention) .
How it helps: For the patient, odor control is essential for social confidence and quality of life. The charcoal filter eliminates the worry of embarrassing smells, while the anti-ballooning feature prevents the pouch from bulging visibly under clothing. The closed design also means that the pouch is never opened for emptying, providing an additional layer of odor containment compared to drainable pouches.

SECONDARY & SUPPORTIVE USES

1. Integration with Flat or Convex Baseplates: The closed 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 .

2. Discreet and Low-Profile Design for Active Lifestyles: The closed 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 .

3. Overnight Use and Sleep Comfort: The closed design is ideal for overnight use; the pouch is simply discarded in the morning and replaced with a fresh one. Some closed pouches feature extra-large capacities for overnight security .

4. Manufacturer System Compatibility: The closed 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.

5. Opaque and Transparent Options: Available in opaque (fabric-covered) for discretion, or transparent for clinical assessment in the post-operative period, allowing clinicians to inspect stoma health and output without removing the appliance .

6. Full-Circle Filter Technology: Some systems feature a full-circle filter that reduces ballooning by up to 61%, improving discretion and helping patients sleep better at night .

7. Compatibility with Ostomy Belts: Many closed pouches are compatible with ostomy belts that clip onto the baseplate, providing additional security during physical activities .

8. Soft Fabric Backing for Comfort: Features a soft, breathable, double-sided non-woven fabric covering the body-facing side to reduce friction, noise, and moisture against the skin .

9. Material Compatibility and Safety: Manufactured without natural rubber latex, making it safe for patients with latex allergies. Complies with ISO 8670-2 (Ostomy collection bags) quality standards .

10. Single-Use, Non-Sterile Design: The closed pouch is a single-use device, intended for use on clean, intact peristomal skin with a properly adhered baseplate. It is non-sterile and should be stored in a cool, dry place .

11. Colostomy-Specific Design: Specifically designed for colostomates with formed or semi-formed stool, where the closed pouch can be used once and then discarded—typically 1-2 pouches per day depending on bowel regularity .

12. Viewing Window for Output Assessment: Many closed pouches include a transparent film viewing window that allows patients to assess stool volume and consistency without removing the pouch, while the opaque fabric covers provide discretion .

13. Coupling Ring Protection: The coupling ring on the pouch is designed to be clean and dry when attached to the baseplate for optimal lock security; if stool contacts the coupling ring, it should be cleaned before attaching a new pouch .

14. Travel and Emergency Use: The closed pouch is ideal for travel, emergency kits, and situations where access to a toilet for emptying a drainable pouch is limited, as the entire pouch is simply discarded .

15. Deodorizing Technology: Some closed 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, closed-end ostomy pouch designed to be attached to a two-piece ostomy baseplate for the collection of formed or semi-formed stool in patients with a colostomy. It is part of a two-piece system where the pouch is exchanged without removing the baseplate .
Designation: Two-piece closed ostomy bag, closed-end colostomy pouch, two-piece closed pouch, non-drainable ostomy bag .
Key Components:

Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH) designed for formed to semi-formed 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: Allows the pouch to be attached and removed without applying pressure to the abdomen near the stoma .
Filter: An integrated activated charcoal filter (full-circle or standard) to allow flatus to escape while containing odor, preventing ballooning .
Comfort Layer: A soft, breathable non-woven fabric covering the body-facing side to reduce friction, noise (rustling), and moisture against the skin .
Closed End: A permanently sealed bottom; no drainage outlet .
Viewing Window: A transparent film section integrated into the front of the pouch to allow for output assessment without removal .

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 permanently sealed (closed-ended). Typically, it is intended to be replaced one to three times per day .
FDA Product Code: EZS - Ostomy Pouch .
Capacity: Standard closed pouch capacity ranges from 500 mL to 1000 mL depending on size and manufacturer. Extra-large capacity pouches available for overnight use .
Coupling Type: Mechanical (flex coupling or guided coupling) with audible click confirmation; floating ring for pressure-free attachment .
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, white, grey, black) for discretion .
Sterility: Non-sterile; intended for use on clean, intact peristomal skin with a properly adhered baseplate .
Single-Use: Intended for single patient, single use only; discard when full .
Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .
Product Characteristics: Non-drainable, odour-proof, non-sterile, single-use .
Special Features: Audible click to confirm bag is safely in place; soft outer layer against the skin; provides discretion and security .
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 closed pouch and baseplate are separate components attached via a mechanical coupling; the closed pouch is exchanged while the baseplate remains on the skin .
Appearance: Available in opaque (fabric-covered) for discretion, or transparent/translucent for clinical assessment. Opaque pouches may be beige, white, grey, or black .
Flexibility: Flexible pouch design that conforms to body movement; some lines feature fabric-like material for an even more discreet, textile-like feel .
Coupling Orientation: Systems may offer multiple coupling positions for optimal pouch orientation .
Wear Time: The closed pouch is changed when full (typically 1-2 times daily for colostomates with formed stool). The baseplate remains in place for 2-3 days while pouches are exchanged .
Packaging: Individually wrapped and sold in boxes; often available in multiple sizes (e.g., 57mm, 70mm flange matching) .
Accessories: May be used with ostomy belts for additional security .
Noise Reduction: Quiet material that does not rustle during movement, with sound-absorbing fabric for discretion .
Odor Control: Multi-layer film provides 100% odor-proof barrier; activated charcoal filter deodorizes escaping gas; some bags feature integrated deodorizing technology .
Viewing Window: Transparent film allows output assessment without removing the pouch, while the fabric cover provides discretion when not being inspected .
Application: Attach to the coupling ring of the baseplate, press until audible click confirms secure locking. The floating ring allows attachment without abdominal pressure .
Removal: Press the release tabs on the coupling ring to detach the closed pouch. The baseplate remains adhered to the skin. Dispose of the used closed 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 .
Storage: Store in a cool, dry place away from direct heat and sunlight, which can degrade the materials .
Expiration: Shelf life varies by manufacturer; 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 and filter. Keep out of reach of children.
Shelf Life: Check individual packaging for expiration date; typically 2-3 years from manufacture .
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 .
Pouch Removal: To remove the closed pouch, gently press the release tabs on the coupling ring. The baseplate remains adhered to the skin. The pouch should be removed when approximately two-thirds full or as clinically indicated .
Disposal: Discard used closed pouch in general waste per local regulations. Do not flush .
Output Monitoring: Use the viewing window to assess stool volume and consistency without removing the pouch .

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Collection and disposal of formed or semi-formed stool following colostomy surgery in patients with predictable, regular bowel movements. The closed pouch is part of a two-piece system where pouches are exchanged without removing the baseplate .
Clinical Role: Essential post-operative and long-term care device in colorectal surgery and home healthcare for the management of patients with a colostomy who produce formed stool and prefer the convenience of a closed, disposable pouch rather than a drainable pouch .

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Indication for Use: The closed two-piece pouch is indicated for patients with a colostomy who produce formed or semi-formed stool and have a regular, predictable bowel pattern (typically 1-2 bowel movements per day). It is not recommended for patients with liquid output (ileostomies) as the pouch would need to be changed too frequently.
Compatibility: The closed 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 liquid stool (ileostomy), a drainable pouch is more appropriate.
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 or under the baseplate .
Output Volume Monitoring: For patients with higher than expected output, ensure the pouch is changed before it becomes overfull (full pouches are more likely to leak). For high-output stomas, consider a high-output pouch or drainable pouch .
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 2-3 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 .
Do Not Reuse: This is a single-use device; do not attempt to wash, resterilize, or reapply a used closed 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.

3. FIRE FIGHTING MEASURES

Flammability: The plastic pouch and non-woven fabric 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 and filter.

Two-piece ostomy bag – Only closed bag

Two-piece ostomy bag – Only closed bag

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Collection of Formed or Semi-Formed Stool Following Colostomy Surgery

Primary Use: Provides a single-use, closed-end ostomy pouch designed to be attached to a two-piece ostomy baseplate (skin barrier/flange) for the collection of formed or semi-formed stool in patients with a colostomy .

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

Primary Use: The two-piece design allows the closed 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. Odor Control and Gas Management

Primary Use: The closed pouch is constructed with multi-layer, 100% odor-proof film and features an integrated activated charcoal filter that allows flatus (gas) to escape while trapping odor molecules, preventing “ballooning” (pouch distention) .

SECONDARY & SUPPORTIVE USES

1. Integration with Flat or Convex Baseplates: The closed 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 .

2. Discreet and Low-Profile Design for Active Lifestyles: The closed 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 .

3. Overnight Use and Sleep Comfort: The closed design is ideal for overnight use; the pouch is simply discarded in the morning and replaced with a fresh one. Some closed pouches feature extra-large capacities for overnight security .

4. Manufacturer System Compatibility: The closed 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.

5. Opaque and Transparent Options: Available in opaque (fabric-covered) for discretion, or transparent for clinical assessment in the post-operative period, allowing clinicians to inspect stoma health and output without removing the appliance .

6. Full-Circle Filter Technology: Some systems feature a full-circle filter that reduces ballooning by up to 61%, improving discretion and helping patients sleep better at night .

7. Compatibility with Ostomy Belts: Many closed pouches are compatible with ostomy belts that clip onto the baseplate, providing additional security during physical activities .

8. Soft Fabric Backing for Comfort: Features a soft, breathable, double-sided non-woven fabric covering the body-facing side to reduce friction, noise, and moisture against the skin .

9. Material Compatibility and Safety: Manufactured without natural rubber latex, making it safe for patients with latex allergies. Complies with ISO 8670-2 (Ostomy collection bags) quality standards .

10. Single-Use, Non-Sterile Design: The closed pouch is a single-use device, intended for use on clean, intact peristomal skin with a properly adhered baseplate. It is non-sterile and should be stored in a cool, dry place .

11. Colostomy-Specific Design: Specifically designed for colostomates with formed or semi-formed stool, where the closed pouch can be used once and then discarded—typically 1-2 pouches per day depending on bowel regularity .

12. Viewing Window for Output Assessment: Many closed pouches include a transparent film viewing window that allows patients to assess stool volume and consistency without removing the pouch, while the opaque fabric covers provide discretion .

13. Coupling Ring Protection: The coupling ring on the pouch is designed to be clean and dry when attached to the baseplate for optimal lock security; if stool contacts the coupling ring, it should be cleaned before attaching a new pouch .

14. Travel and Emergency Use: The closed pouch is ideal for travel, emergency kits, and situations where access to a toilet for emptying a drainable pouch is limited, as the entire pouch is simply discarded .

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

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A single-use, closed-end ostomy pouch designed to be attached to a two-piece ostomy baseplate for the collection of formed or semi-formed stool in patients with a colostomy. It is part of a two-piece system where the pouch is exchanged without removing the baseplate .

Designation: Two-piece closed ostomy bag, closed-end colostomy pouch, two-piece closed pouch, non-drainable ostomy bag .

Key Components:

Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH) designed for formed to semi-formed 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: Allows the pouch to be attached and removed without applying pressure to the abdomen near the stoma .

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

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

Closed End: A permanently sealed bottom; no drainage outlet .

Viewing Window: A transparent film section integrated into the front of the pouch to allow for output assessment without removal .

2. TECHNICAL & PERFORMANCE PROPERTIES

FDA Product Code: EZS - Ostomy Pouch .

Capacity: Standard closed pouch capacity ranges from 500 mL to 1000 mL depending on size and manufacturer. Extra-large capacity pouches available for overnight use .

Coupling Type: Mechanical (flex coupling or guided coupling) with audible click confirmation; floating ring for pressure-free attachment .

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, white, grey, black) for discretion .

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

Single-Use: Intended for single patient, single use only; discard when full .

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

Product Characteristics: Non-drainable, odour-proof, non-sterile, single-use .

Special Features: Audible click to confirm bag is safely in place; soft outer layer against the skin; provides discretion and security .

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 closed pouch and baseplate are separate components attached via a mechanical coupling; the closed pouch is exchanged while the baseplate remains on the skin .

Appearance: Available in opaque (fabric-covered) for discretion, or transparent/translucent for clinical assessment. Opaque pouches may be beige, white, grey, or black .

Flexibility: Flexible pouch design that conforms to body movement; some lines feature fabric-like material for an even more discreet, textile-like feel .

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

Wear Time: The closed pouch is changed when full (typically 1-2 times daily for colostomates with formed stool). The baseplate remains in place for 2-3 days while pouches are exchanged .

Packaging: Individually wrapped and sold in boxes; often available in multiple sizes (e.g., 57mm, 70mm flange matching) .

Accessories: May be used with ostomy belts for additional security .

Noise Reduction: Quiet material that does not rustle during movement, with sound-absorbing fabric for discretion .

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

Viewing Window: Transparent film allows output assessment without removing the pouch, while the fabric cover provides discretion when not being inspected .

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

Removal: Press the release tabs on the coupling ring to detach the closed pouch. The baseplate remains adhered to the skin. Dispose of the used closed 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 .

Storage: Store in a cool, dry place away from direct heat and sunlight, which can degrade the materials .

Expiration: Shelf life varies by manufacturer; 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 and filter. Keep out of reach of children.

Shelf Life: Check individual packaging for expiration date; typically 2-3 years from manufacture .

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 .

Pouch Removal: To remove the closed pouch, gently press the release tabs on the coupling ring. The baseplate remains adhered to the skin. The pouch should be removed when approximately two-thirds full or as clinically indicated .

Disposal: Discard used closed pouch in general waste per local regulations. Do not flush .

Output Monitoring: Use the viewing window to assess stool volume and consistency without removing the pouch .

6. LABORATORY & CLINICAL APPLICATIONS