Identity
- Trade Name
- Navina™ Smart System Small FDA UDI
- Generic Name
- Powered rectal/colostomy irrigation system FDA UDI
- Device Name
- Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 2 Rectal catheters small, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only. FDA UDI
- Model / Reference
- 69010 FDA UDI
- Description
- Navina Smart Transanal Irrigation. 1 Navina Smart control unit, 1 Water container, 1 Tube set, 2 Rectal catheters small, 1 Accessory set, 1 Navina case. Non Sterile Device. Rx Only. FDA UDI
Identifiers
- Catalog Number
- 6901040 FDA UDI
- Primary DI / UDI-DI
- 07392532243950 FDA UDI
- FDA Product Code
- FCE FDA UDIKNT FDA UDI
- GMDN Term
- Powered rectal/colostomy irrigation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5210 FDA UDI876.5980 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Navina™ Smart System Small by Wellspect AB — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Wellspect AB
Sources (1)
- FDA UDI 4e6cbddb-afa6-4c7b-9ff3-2abcd334ce56 37 fields · synced Jun 8, 2026