Peristeen Plus

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name: Peristeen Plus FDA UDI
Generic Name: Rectal irrigation kit FDA UDI
Device Name: Peristeen Plus Transanal irrigation / Peristeen Plus . Balloon catheter. 15 balloon catheters Small 1 water bag. FDA UDI
Model / Reference: 29149 FDA UDI
Description: Peristeen Plus Transanal irrigation / Peristeen Plus . Balloon catheter. 15 balloon catheters Small 1 water bag. FDA UDI

Identifiers

Catalog Number: 29149 FDA UDI
Primary DI / UDI-DI: 05701780237765 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Peristeen Plus by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Navina™ Consumable Set Regular — Wellspect AB · Class II
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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: Coloplast A/S

Sources (1)

FDA UDI 17065fc3-9722-4398-b178-5cdae8c47e77 36 fields · synced Jun 1, 2026