Peristeen Plus

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name: Peristeen Plus FDA UDI
Generic Name: Rectal/colonic irrigation nozzle, single-use FDA UDI
Device Name: Peristeen Plus Transanal irrigation / Peristeen Plus . Balloon catheter. FDA UDI
Model / Reference: 29143 FDA UDI
Description: Peristeen Plus Transanal irrigation / Peristeen Plus . Balloon catheter. FDA UDI

Identifiers

Catalog Number: 29143 FDA UDI
Primary DI / UDI-DI: 05701780236225 FDA UDI
FDA Product Code: KNT FDA UDI
FCE FDA UDI
GMDN Term: Rectal/colonic irrigation nozzle, single-use 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/colonic irrigation nozzle, single-use

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

Similar devices

Also classified as Rectal/colonic irrigation nozzle, single-use.

Bard® Colon Tubes — C. R. Bard, Inc. · Class II
Bard® Colon Tubes — C. R. Bard, Inc. · Class II
Bard® Rectal Tubes — C. R. Bard, Inc. · Class II
Pro-Fit — Prime Pacific Health Innovations Corporation · Class I
Bard® Rectal Tubes — C. R. Bard, Inc. · Class II
Colonic Irrigation Nozzle — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
Pro-Fit — Prime Pacific Health Innovations Corporation · Class I
Bard® Colon Tubes — C. R. Bard, Inc. · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Coloplast A/S

Sources (1)

FDA UDI 057da646-3e09-4523-bad4-cfc17b72949f 36 fields · synced Jun 8, 2026