Identity
- Trade Name
- WATER PUMP TUBIG KIT FDA UDI
- Generic Name
- Urological irrigation system FDA UDI
- Device Name
- Urodynamic testing / Cystomery FDA UDI
- Model / Reference
- ONG03399ST280 FDA UDI
- Description
- Urodynamic testing / Cystomery FDA UDI
Identifiers
- Catalog Number
- 84411165-2 FDA UDI
- Primary DI / UDI-DI
- 03700512906223 FDA UDI
- FDA Product Code
- FEN FDA UDI
- GMDN Term
- Urological irrigation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1620 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Urological irrigation system
Water Pump Tubig Kit by Promepla — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mediplus — Mediplus , Ltd. · 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
- Promepla
Sources (1)
- FDA UDI 8082b151-3e0a-4c26-a3e2-e907c4d59b12 34 fields · synced May 30, 2026