Identity
- Trade Name
- Coulmed FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Non-Sterile Uro-Catcher Drain Bag; fits all hoop-style frames. Includes: Under Buttox Flaps, Mesh Filter, 6' Flexible Drain Tube with Adapter FDA UDI
- Model / Reference
- A5313-NS FDA UDI
- Description
- Non-Sterile Uro-Catcher Drain Bag; fits all hoop-style frames. Includes: Under Buttox Flaps, Mesh Filter, 6' Flexible Drain Tube with Adapter FDA UDI
Identifiers
- Catalog Number
- A5313-NS FDA UDI
- Primary DI / UDI-DI
- 10810087350502 FDA UDI
- FDA Product Code
- NNW FDA UDI
- GMDN Term
- Non-wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-wearable adult urine collection bag, open-ended
Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coulmed Products Group Llc
Sources (1)
- FDA UDI c84d4f69-9f0b-40bb-b751-9cd621b2d3ca 34 fields · synced Jun 8, 2026