Identity
- Trade Name
- Duo Wipeable Black cover FDA UDI
- Generic Name
- Medical cushion cover FDA UDI
- Device Name
- Trulife Wheelchair Cushion Cover, Relax Duogel DWC003-17 FDA UDI
- Model / Reference
- DWC003-17 FDA UDI
- Description
- Trulife Wheelchair Cushion Cover, Relax Duogel DWC003-17 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293006214 FDA UDI
- FDA Product Code
- IMP FDA UDI
- GMDN Term
- Medical cushion cover FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3920 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical cushion cover
Duo Wipeable Black cover by Trulife Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical cushion cover.
- Action® — Action Products, Inc. · Class I
- Jenx — JENX LIMITED · Class I
- Jenx — JENX LIMITED · Class I
- Action® — Action Products, Inc. · Class I
- Jenx — JENX LIMITED · Class I
- Jenx — JENX LIMITED · Class I
- Action® — Action Products, Inc. · Class I
- Jenx — JENX LIMITED · 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
- Trulife Limited
Sources (1)
- FDA UDI 30b39859-2d40-46c1-ab25-435be6c37f9c 33 fields · synced Jun 8, 2026