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Peristeen Plus

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Peristeen Plus FDA UDI
Generic Name
Manual rectal irrigation system control unit FDA UDI
Device Name
Peristeen Plus Transanal irrigation / Peristeen Plus Transanal Irrigation. System without a catheter. 1 control unit; 1 water bag (incl. screw top); 2 straps; 1 tube. FDA UDI
Model / Reference
29152 FDA UDI
Description
Peristeen Plus Transanal irrigation / Peristeen Plus Transanal Irrigation. System without a catheter. 1 control unit; 1 water bag (incl. screw top); 2 straps; 1 tube. FDA UDI

Identifiers

Catalog Number
29152 FDA UDI
Primary DI / UDI-DI
05708932732642 FDA UDI
FDA Product Code
KNT FDA UDI
FCE FDA UDI
GMDN Term
Manual rectal irrigation system control unit 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

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

No

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

Category: Manual rectal irrigation system control unit

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

Similar devices

Also classified as Manual rectal irrigation system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI b523bc57-afd8-405a-a4ad-79a12dce7421 35 fields · synced Jun 8, 2026