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Navina™Consumable Set Small

FDA UDI

Class II (US FDA UDI)

by Wellspect AB

Identity

Trade Name
Navina™Consumable Set Small FDA UDI
Generic Name
Rectal irrigation kit FDA UDI
Device Name
Navina Transanal Irrigation. Consumable set small. 1 Water container, 15 Rectal catheters small. Non Sterile device. Rx Only. FDA UDI
Model / Reference
69004 FDA UDI
Description
Navina Transanal Irrigation. Consumable set small. 1 Water container, 15 Rectal catheters small. Non Sterile device. Rx Only. FDA UDI

Identifiers

Catalog Number
6900440 FDA UDI
Primary DI / UDI-DI
07392532243868 FDA UDI
FDA Product Code
KNT FDA UDI
FCE FDA UDI
GMDN Term
Rectal irrigation kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
876.5210 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™Consumable Set Small by Wellspect AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wellspect AB

Sources (1)

  • FDA UDI fb2f283f-a26b-4c4c-a8bf-1c0df2013c97 37 fields · synced Jun 7, 2026