Identity
- Trade Name
- hygh-tec FDA UDI
- Generic Name
- Faecal incontinence collector, catheterization FDA UDI
- Device Name
- hygh-tec® bag stool collection bag | 10 pcs FDA UDI
- Model / Reference
- V01-10026-10 FDA UDI
- Description
- hygh-tec® bag stool collection bag | 10 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260566430154 FDA UDI
- 510(k) Number
- K221400 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Faecal incontinence collector, catheterization 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Faecal incontinence collector, catheterization
hygh-tec by Advanced Medical Balloons GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal incontinence collector, catheterization.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- FLEXI-SEAL — CONVATEC, PURCHASING DEPARTMENT · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K221400 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Medical Balloons GmbH
Sources (1)
- FDA UDI dc5c1a61-165b-4a6f-8f8f-ace5bcf84f70 36 fields · synced Jun 6, 2026