Identity
- Trade Name
- Foam Mattress Pads FDA UDI
- Generic Name
- Freestanding patient positioner, single-use FDA UDI
- Device Name
- QUEEN Convolute Mattress Topper 4" X 60" X 80" Density # 1.2 FDA UDI
- Model / Reference
- CM-46080D FDA UDI
- Description
- QUEEN Convolute Mattress Topper 4" X 60" X 80" Density # 1.2 FDA UDI
Identifiers
- Catalog Number
- CM-46080D FDA UDI
- Primary DI / UDI-DI
- 00810044960631 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Freestanding patient positioner, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Freestanding patient positioner, single-use
Foam Mattress Pads by Geneva Healthcare, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding patient positioner, single-use.
- Span-America — Span-America Medical Systems, Inc. · Class I
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Soule Medical — SOULE CO., THE · Class I
- 40527 DermaProx Pad 8'' x 11'' x 1/2'' — XODUS MEDICAL, INC. · Class I
- American Hospital Supply — AMERICAN HOSPITAL SUPPLY · Class I
- Prime Medical LLC — Prime Medical LLC · Class I
- HALYARD — OWENS & MINOR DISTRIBUTION, INC. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · 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
- Geneva Healthcare, Llc
Sources (1)
- FDA UDI 7326a81b-6587-4420-9607-3d50dc9cbadd 35 fields · synced May 29, 2026