Skip to content

Burke Inc Tri-Flex Air

by Burke, Inc.

Burke Inc Tri-Flex Air (63390) is an alternating-pressure bed mattress overlay system (FDA Class II; FDA product code FNM, Mattress, Air Flotation, Alternating Pressure) made by Burke, Inc., listed in FDA GUDID since 1 Sep 2016 (UDI-DI B314633901), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB314633901 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Burke Inc
Generic name
Alternating-pressure bed mattress overlay system
Model / Ref / Catalog
Tri-Flex Air, 63390
Primary DI / UDI-DI
B314633901
FDA product code
FNM
GMDN term
Alternating-pressure bed mattress overlay system
Device class
Class II
Regulation number
880.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Alternating-pressure bed mattress overlay system

Similar devices

Other devices filed under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure).

Other devices from Burke, Inc.

See all devices from Burke, Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)