Identity
- Trade Name
- Burke FDA UDI
- Generic Name
- Orthopaedic bed mattress FDA UDI
- Device Name
- Foam Mattress w/ bolsters - 48" FDA UDI
- Model / Reference
- Bari-Float Mattress 48" FDA UDI
- Description
- Foam Mattress w/ bolsters - 48" FDA UDI
Identifiers
- Catalog Number
- 63187 FDA UDI
- Primary DI / UDI-DI
- B314631871 FDA UDI
- FDA Product Code
- IKY FDA UDI
- GMDN Term
- Orthopaedic bed mattress FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bed mattress
Burke by Burke, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bed mattress.
- ThevoFlex FR 308 lbs, Hospital size 36x79", inco — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Class I
- ThevoCalm FR 176 lbs, Queen size 60x79", jersey white — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Class I
- FusionXC — MOXI ENTERPRISES, LLC · Class I
- ThevoCalm FR 176 lbs, Twin size 39x75”, jersey — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Class I
- ThevoRelief FR 220 lbs, Split Queen 30x79", jersey white — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Class I
- ThevoRelief FR 220 lbs, Split King 38x79", jersey white — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Class I
- ThevoautoActiv FR 110 lbs, Hospital size 35x79", jersey white — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Class I
- ThevoSleepingStar FR 132 lbs, Full Size 54x75", Jersey white — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · 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
- Burke, Inc.
Sources (1)
- FDA UDI a8a16ee5-8b4c-4658-928c-f3e77fe2d750 35 fields · synced Jun 8, 2026