Navina™Consumable Set Cone

FDA UDI

Class I (US FDA UDI)

by Wellspect AB

Identity

Trade Name: Navina™Consumable Set Cone FDA UDI
Generic Name: Rectal irrigation kit FDA UDI
Device Name: Navina Transanal Irrigation. Consumable set cone. 1 Water container, 15 Rectal catheters cone. Non Sterile device. Rx Only. FDA UDI
Model / Reference: 69016 FDA UDI
Description: Navina Transanal Irrigation. Consumable set cone. 1 Water container, 15 Rectal catheters cone. Non Sterile device. Rx Only. FDA UDI

Identifiers

Catalog Number: 6901640 FDA UDI
Primary DI / UDI-DI: 07333387029016 FDA UDI
FDA Product Code: FCE FDA UDI
KNT FDA UDI
GMDN Term: Rectal irrigation kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5210 FDA UDI
876.5980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Rectal irrigation kit

Navina™Consumable Set Cone by Wellspect AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Wellspect AB

Sources (1)

FDA UDI 209c48e3-fafc-4a11-9742-0229b23c8fa5 36 fields · synced May 31, 2026