Burke Tri-Flex II
by Burke, Inc.
Burke Tri-Flex II (63398B) is a bariatric bed (FDA Class II; FDA product code FNL, Bed, Ac-Powered Adjustable Hospital) made by Burke, Inc., listed in FDA GUDID since 1 Sep 2016 (UDI-DI B31463398B1), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB31463398B1 | Date1 Sep 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Burke
- Generic name
- Bariatric bed
- Model / Ref / Catalog
- Tri-Flex II, 63398B
- Primary DI / UDI-DI
- B31463398B1
- FDA product code
- FNL
- GMDN term
- Bariatric bed
- Device class
- Class II
- Regulation number
- 880.5100
- GUDID distribution status
- In Commercial Distribution
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