Identity
- Trade Name
- Coolcell Spacer Fabric Cover FDA UDI
- Generic Name
- Medical cushion cover FDA UDI
- Device Name
- Trulife Relax Wheelchair Cover, Gelcell/Coolcell Black Cover 1616 FDA UDI
- Model / Reference
- CC004-1616 FDA UDI
- Description
- Trulife Relax Wheelchair Cover, Gelcell/Coolcell Black Cover 1616 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293028827 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
Coolcell Spacer Fabric Cover by Trulife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Trulife, Inc.
Sources (1)
- FDA UDI 572bd645-2634-4063-befe-a9b45c906e85 33 fields · synced Jun 4, 2026