Identity
- Trade Name
- Mediplus FDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- Triple lumen UPP catheter 7fr latex free FDA UDI
- Model / Reference
- 5333 FDA UDI
- Description
- Triple lumen UPP catheter 7fr latex free FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055140701855 FDA UDI
- FDA Product Code
- FEN FDA UDI
- GMDN Term
- Urodynamic measurement 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
Dimensions & Sizes
- Size
- Length — 40.0 Centimeter FDA UDICatheter Gauge — 7.0 French 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 71abcd7d-41cb-454a-a6be-d4ce47d8a16d 36 fields · synced Jun 6, 2026