Burke Inc 63390

GUDID B314633901

Alternating-pressure bed mattress overlay system

Primary Device ID	B314633901
NIH Device Record Key	da57e2ce-d4c4-4344-a86d-0a9abee9b61f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Burke Inc
Version Model Number	Tri-Flex Air
Catalog Number	63390
Company DUNS	045093101
Company Name	BURKE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B314633901 [Primary]

FNM	Mattress, Air Flotation, Alternating Pressure

Steralize Prior To Use	false
Device Is Sterile	false