Identity
- Trade Name
- PEDIATRIC URINE COLLECTORS, CLEAN FDA UDI
- Generic Name
- Adhesive paediatric urine collection bag, open-ended FDA UDI
- Device Name
- PEDIATRIC URINE COLLECTORS, CLEAN, 100/Box, 500/Case FDA UDI
- Model / Reference
- 05001 FDA UDI
- Description
- PEDIATRIC URINE COLLECTORS, CLEAN, 100/Box, 500/Case FDA UDI
Identifiers
- Catalog Number
- 05001-00-SCB (Y5178897) FDA UDI
- Primary DI / UDI-DI
- 10687225793749 FDA UDI
- FDA Product Code
- NOA FDA UDI
- GMDN Term
- Adhesive paediatric 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
Yes
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: Adhesive paediatric urine collection bag, open-ended
Pediatric Urine Collectors, Clean by Precision Dynamics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Adhesive paediatric urine collection bag, open-ended.
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- ENDURE INDUSTRIES — ENDURE INDUSTRIES, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- ENDURE INDUSTRIES — ENDURE INDUSTRIES, INC. · Class II
- PEDIATRIC URINE COLLECTORS, STERILE — PRECISION DYNAMICS CORPORATION · Class I
- UR-Assure — PRECISION DYNAMICS CORPORATION · Class I
- UR-Assure — PRECISION DYNAMICS CORPORATION · Class I
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
- Precision Dynamics Corporation
Sources (1)
- FDA UDI 798bcbe9-30a8-46d4-8ea8-927fb12f7bc2 34 fields · synced Jun 6, 2026