Identity
- Trade Name
- Pediatric Urine Collector FDA UDI
- Generic Name
- Wearable paediatric urine collection bag FDA UDI
- Device Name
- Pediatric Urine Collector, 200mL FDA UDI
- Model / Reference
- 4283 FDA UDI
- Description
- Pediatric Urine Collector, 200mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784428314 FDA UDI
- FDA Product Code
- KNX FDA UDIEXI FDA UDI
- GMDN Term
- Wearable paediatric urine collection bag 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Wearable paediatric urine collection bag
Pediatric Urine Collector 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 70639142-0abb-4418-8b4a-25b12609213b 33 fields · synced Jun 8, 2026