Identity
- Trade Name
- Navina Mini Extension Set FDA UDI
- Generic Name
- Manual rectal irrigation system FDA UDI
- Device Name
- Navina Mini Extension Set. 1 Water Container, 30 Rectal Cones. 1 extension tube. Non Sterile Device. FDA UDI
- Model / Reference
- 6930840 FDA UDI
- Description
- Navina Mini Extension Set. 1 Water Container, 30 Rectal Cones. 1 extension tube. Non Sterile Device. FDA UDI
Identifiers
- Catalog Number
- 6930840 FDA UDI
- Primary DI / UDI-DI
- 07333387052830 FDA UDI
- FDA Product Code
- FCE FDA UDI
- GMDN Term
- Manual rectal irrigation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5210 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Category: Manual rectal irrigation system
Navina Mini Extension Set by Wellspect AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual rectal irrigation system.
- Peristeen — Coloplast A/S · Class II
- Centurion — Centurion Medical Products · Class II
- Peristeen — Coloplast A/S · Class II
- Navina™ Classic System Regular — Wellspect AB · Class II
- Navina™ Mini Start Set — Wellspect AB · Class I
- Navina™ Classic System Refill — Wellspect AB · Class II
- Navina™ Classic System Small Refill — Wellspect AB · Class I
- Navina™ Classic System Regular Refill — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Wellspect AB
Sources (1)
- FDA UDI 303e2047-bf93-4cee-931e-60c945d5e0b4 35 fields · synced Jun 1, 2026