Identity
- Trade Name
- ActiFlo FDA UDI
- Generic Name
- Faecal incontinence kit FDA UDI
- Device Name
- Bowel Catheter System, Drainable Kit FDA UDI
- Model / Reference
- 32005 FDA UDI
- Description
- Bowel Catheter System, Drainable Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610075179633 FDA UDI
- 510(k) Number
- K083153 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Faecal incontinence kit 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
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
Yes
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
Dimensions & Sizes
- Size
- Length — 6 Centimeter FDA UDI
Category: Faecal incontinence kit
ActiFlo by Hollister Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal incontinence kit.
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- FLEXI-SEAL — CONVATEC, PURCHASING DEPARTMENT · Class II
- Bard® DigniShield® Stool Management System — C. R. Bard, Inc. · Class II
- Qora AIM Stool Management Kit — Consure Medical Private Limited · Class II
- Qora Aeon Stool Management Kit — Consure Medical Private Limited · Class II
Cleared under the same submission
K083153 also covers:
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
- Hollister Incorporated
Sources (1)
- FDA UDI bd74976d-3e45-475a-9ae1-6cfbb5d14f61 37 fields · synced Jun 9, 2026