Identity
- Trade Name
- CareOne FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Hydrogel Burn Pads, all one size, 1.96 IN x 2.95 IN FDA UDI
- Model / Reference
- 041520089359 FDA UDI
- Description
- Hydrogel Burn Pads, all one size, 1.96 IN x 2.95 IN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00041520089359 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Wound hydrogel dressing, non-antimicrobial
CareOne by Ahold U.S.A., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, non-antimicrobial.
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- MYNX CONTROL — Accessclosure, Inc. · Class III
- HydroTac transparent 10x10cm steril P10 — Paul Hartmann Corp. · Class I
- Hyalo4 Care Clear Hydrogel, 100g — Fidia Farmaceutici · U
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Simpurity — SAFE N SIMPLE LLC · Class I
- Halo — Medical Devices Inc. · 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 |
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Manufacturer
- Manufacturer
- Ahold U.S.A., Inc.
Sources (1)
- FDA UDI 1048fe93-0878-4f05-9b42-f5cd3fd4d8bd 33 fields · synced May 30, 2026