Identity
- Trade Name
- Qora AIM Stool Management Kit FDA UDI
- Generic Name
- Faecal incontinence kit FDA UDI
- Model / Reference
- MG-01975-002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860974000303 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Faecal incontinence kit
Qora AIM Stool Management Kit by Consure Medical Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal incontinence kit.
- hygh-tec — Advanced Medical Balloons GmbH · Class II
- FLEXI-SEAL — CONVATEC, PURCHASING DEPARTMENT · Class I
- hygh-tec — Advanced Medical Balloons GmbH · Class II
- InstaFlo — Hollister Incorporated · Class II
- FLEXI-SEAL — CONVATEC, PURCHASING DEPARTMENT · Class I
- FLEXI-SEAL — CONVATEC, PURCHASING DEPARTMENT · Class II
- Bard® DigniShield® Stool Management System — C. R. Bard, Inc. · Class II
- ActiFlo — Hollister Incorporated · 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
- Consure Medical Private Limited
Sources (1)
- FDA UDI 15f222a6-f92e-421b-9ffb-46e5b1cdbbc2 32 fields · synced May 30, 2026