Identity
- Trade Name
- ENDURE INDUSTRIES FDA UDI
- Generic Name
- Adhesive paediatric urine collection bag, open-ended FDA UDI
- Device Name
- Urine Collector, Pediatric 100 ml FDA UDI
- Model / Reference
- PUC1A8 FDA UDI
- Description
- Urine Collector, Pediatric 100 ml FDA UDI
Identifiers
- Catalog Number
- PUC1A8 FDA UDI
- Primary DI / UDI-DI
- 00840118611596 FDA UDI
- FDA Product Code
- FFH FDA UDI
- GMDN Term
- Adhesive paediatric urine collection bag, open-ended 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
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
Yes
FDA UDI
Category: Adhesive paediatric urine collection bag, open-ended
Endure Industries by Endure Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Adhesive paediatric urine collection bag, open-ended.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- PEDIATRIC URINE COLLECTORS, STERILE — PRECISION DYNAMICS CORPORATION · Class I
- PEDIATRIC URINE COLLECTORS, CLEAN — PRECISION DYNAMICS CORPORATION · Class I
- UR-Assure — PRECISION DYNAMICS CORPORATION · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- UR-Assure — PRECISION DYNAMICS CORPORATION · Class I
- ENDURE INDUSTRIES — ENDURE INDUSTRIES, INC. · Class II
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
- Endure Industries, Inc.
Sources (1)
- FDA UDI 7a84f05d-5cb8-4687-9a8d-c19412ef71a8 36 fields · synced May 30, 2026