Identity
- Trade Name
- Mediplus FDA UDI
- Generic Name
- Urological irrigation system FDA UDI
- Device Name
- Extension Line with one way valve, 20cm FDA UDI
- Model / Reference
- 5183 FDA UDI
- Description
- Extension Line with one way valve, 20cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055140703040 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 3.0 Millimeter FDA UDI
Category: Urological irrigation system
Mediplus by Mediplus , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urological irrigation system.
- WATER PUMP TUBIG KIT — Promepla · Class II
- Mediplus — Mediplus , Ltd. · Class II
- Mediplus — Mediplus , Ltd. · Class II
- Mediplus — Mediplus , Ltd. · Class II
- Morpheus — Mediplus , Ltd. · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mediplus , Ltd.
Sources (1)
- FDA UDI 701cca87-4c2e-4d0a-bc72-6e532b9adb67 35 fields · synced Jun 1, 2026