Identity
- Trade Name
- Burke Inc FDA UDI
- Generic Name
- Alternating-pressure bed mattress overlay system FDA UDI
- Device Name
- Air Mattress, Low Air Loss FDA UDI
- Model / Reference
- Tri-Flex Air FDA UDI
- Description
- Air Mattress, Low Air Loss FDA UDI
Identifiers
- Catalog Number
- 63390 FDA UDI
- Primary DI / UDI-DI
- B314633901 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Alternating-pressure bed mattress overlay system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5550 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: Alternating-pressure bed mattress overlay system
Burke Inc by Burke, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Burke, Inc.
Sources (1)
- FDA UDI da57e2ce-d4c4-4344-a86d-0a9abee9b61f 35 fields · synced May 30, 2026