Identity
- Trade Name
- Peristeen FDA UDI
- Generic Name
- Manual rectal irrigation system FDA UDI
- Device Name
- Peristeen Transanal Irrigation. Tube. 2 tubes. Non sterile. Rx only. FDA UDI
- Model / Reference
- 29125 FDA UDI
- Description
- Peristeen Transanal Irrigation. Tube. 2 tubes. Non sterile. Rx only. FDA UDI
Identifiers
- Catalog Number
- 29125 FDA UDI
- Primary DI / UDI-DI
- 05708932487047 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Manual rectal irrigation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
Peristeen by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Navina™ Classic System Regular Refill — Wellspect AB · Class II
- Navina™ Classic System Regular — Wellspect AB · 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 8e961ec4-e21a-49d6-abc5-faf9291ff04a 36 fields · synced May 30, 2026