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Navina™ Rectal Catheter Set Regular
FDA UDIClass II (US FDA UDI)
by Wellspect AB
Identity
- Trade Name
- Navina™ Rectal Catheter Set Regular FDA UDI
- Generic Name
- Rectal irrigation kit FDA UDI
- Device Name
- Navina Transanal Irrigation. Rectal Catheter set regular. 10 Rectal catheters regular. Single use. Non sterile Device. Rx Only. FDA UDI
- Model / Reference
- 68940 FDA UDI
- Description
- Navina Transanal Irrigation. Rectal Catheter set regular. 10 Rectal catheters regular. Single use. Non sterile Device. Rx Only. FDA UDI
Identifiers
- Catalog Number
- 6894040 FDA UDI
- Primary DI / UDI-DI
- 07333387024745 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Rectal irrigation kit 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
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
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: Rectal irrigation kit
Navina™ Rectal Catheter Set Regular by Wellspect AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal irrigation kit.
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- Navina Mini Refill Set — Wellspect AB · Class I
- Navina™ Catheter Set Small — Wellspect AB · Class I
- Navina™Consumable Set Small — Wellspect AB · Class I
- Navina™ Consumable Set Regular — Wellspect AB · 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 |
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Manufacturer
- Manufacturer
- Wellspect AB
Sources (1)
- FDA UDI cb297e34-91e2-4650-b5dc-935b3f1c9ba3 35 fields · synced May 29, 2026