Identity
- Trade Name
- Abena FDA UDI
- Generic Name
- Adult nappy FDA UDI
- Device Name
- Abri-Form Premium Adult incontinence holds 68 fluid ounces/2000 ml, for individuals with waist and hip measurements from 40" to 60". Generally is classified as a Large size. FDA UDI
- Model / Reference
- 43059 FDA UDI
- Description
- Abri-Form Premium Adult incontinence holds 68 fluid ounces/2000 ml, for individuals with waist and hip measurements from 40" to 60". Generally is classified as a Large size. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05703538012204 FDA UDI
- FDA Product Code
- EYQ FDA UDI
- GMDN Term
- Adult nappy FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5920 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Adult nappy
Abena by Abena North America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Adult nappy.
- Clever Choice — SIMPLE DIAGNOSTICS · Class I
- TENA — Essity Hygiene and Health AB · Class II
- FLUFSAN — EUROPROSAN SPA · Class I
- CUSTOMED — Customed, Inc. · Class I
- Topmed — Xiantao Topmed Nonwoven Protective Products Co., Ltd. · Class I
- Resilient Medical Solutions — Resilient Medical Solutions, LLC · Class I
- BrightCare Medsoft — THE GILBERT GROUP LLC · Class I
- FLUFSAN — EUROPROSAN SPA · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abena North America, Inc.
Sources (1)
- FDA UDI 3a7c4cd8-ee94-47b0-affc-2ba09a4f84fb 36 fields · synced May 30, 2026