Identity
- Trade Name
- Navina™ Consumable Set Regular FDA UDI
- Generic Name
- Rectal irrigation kit FDA UDI
- Device Name
- Navina Transanal Irrigation. Consumable set regular. 1 Water container, 15 Rectal catheters regular. Non Sterile device. Rx Only. FDA UDI
- Model / Reference
- 69003 FDA UDI
- Description
- Navina Transanal Irrigation. Consumable set regular. 1 Water container, 15 Rectal catheters regular. Non Sterile device. Rx Only. FDA UDI
Identifiers
- Catalog Number
- 6900340 FDA UDI
- Primary DI / UDI-DI
- 07333387025292 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
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
Category: Rectal irrigation kit
Navina™ Consumable 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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- Peristeen Plus — Coloplast A/S · Class II
- Navina Mini Refill Set — Wellspect AB · Class I
- Navina™ Rectal Catheter Set Regular — Wellspect AB · Class II
- Navina™ Catheter Set Small — Wellspect AB · Class I
- Navina™Consumable Set Small — 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 49e27446-f6a3-4baa-a75e-8666f481b087 35 fields · synced May 30, 2026