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 . FDA UDI
- Model / Reference
- 29150 FDA UDI
- Description
- Peristeen Plus Transanal irrigation / Peristeen Plus . FDA UDI
Identifiers
- Catalog Number
- 29150 FDA UDI
- Primary DI / UDI-DI
- 05701780238199 FDA UDI
- FDA Product Code
- KNT FDA UDIFCE FDA UDI
- GMDN Term
- Rectal/colonic irrigation nozzle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI876.5210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: 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 |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 0cb1ddbb-2a46-4fd1-a8b3-033571383140 36 fields · synced May 31, 2026