Identity
- Trade Name
- Urinary Drainage Bag Holder FDA UDI
- Generic Name
- Open-ended non-wearable urine collection bag, non-sterile FDA UDI
- Model / Reference
- 10261 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784026138 FDA UDI
- FDA Product Code
- KNX FDA UDI
- GMDN Term
- Open-ended non-wearable urine collection bag, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Open-ended non-wearable urine collection bag, non-sterile
Urinary Drainage Bag Holder by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 7d903c36-5bc5-4535-a152-978a52c7ba7c 32 fields · synced May 31, 2026