Identity
- Trade Name
- Navina™ Classic Control Unit FDA UDI
- Generic Name
- Powered rectal irrigation system control unit FDA UDI
- Device Name
- Navina Classic Transanal Irrigation. 1 Navina Classic control unit. Non Sterile Device. Rx Only. FDA UDI
- Model / Reference
- 69013 FDA UDI
- Description
- Navina Classic Transanal Irrigation. 1 Navina Classic control unit. Non Sterile Device. Rx Only. FDA UDI
Identifiers
- Catalog Number
- 6901340 FDA UDI
- Primary DI / UDI-DI
- 07333387028330 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Powered rectal irrigation system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Powered rectal irrigation system control unit
Navina™ Classic Control Unit by Wellspect AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Powered rectal irrigation system control unit.
- Navina™ Smart Control Unit — Wellspect AB · Class I
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
- Wellspect AB
Sources (1)
- FDA UDI 1d0c8a7b-e718-4e7f-9e9a-2fd5aa41e05f 35 fields · synced May 30, 2026