Identity
- Trade Name
- Mediplus FDA UDI
- Generic Name
- Urological irrigation system FDA UDI
- Device Name
- Catheter flushing set, 3-way FDA UDI
- Model / Reference
- 5625 FDA UDI
- Description
- Catheter flushing set, 3-way FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055140700247 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
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mediplus by Mediplus , Ltd. — 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
- Mediplus , Ltd.
Sources (1)
- FDA UDI 39801fb1-1c3b-49c6-a1fc-1d861e0d07a3 35 fields · synced May 30, 2026