BiFLo™ 0101

GUDID 20889483227265

Oxygen administration face tent

Primary Device ID	20889483227265
NIH Device Record Key	ee1420a1-ca30-4242-8fe2-aa9fa9c3fd2b
Commercial Distribution Status	In Commercial Distribution
Brand Name	BiFLo™
Version Model Number	0101
Catalog Number	0101
Company DUNS	069009268
Company Name	SUNMED, LLC
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00709078004308 [Previous]
GS1	10889483227268 [Primary]
GS1	20889483227265 [Package] Contains: 10889483227268 Package: Box [25 Units] In Commercial Distribution

BYG	Mask, Oxygen

Steralize Prior To Use	false
Device Is Sterile	false

20889483227272	BiFLo™ Mask
20889483227265	BiFLo™ Mask \

Mark Image Registration \| Serial	Company Trademark Application Date
BIFLO 78844696 not registered Dead/Abandoned	Critical Therapeutics, Inc. 2006-03-23
BIFLO 75588511 not registered Dead/Abandoned	Glaxo Wellcome Inc. 1998-11-13
BIFLO 75359653 not registered Dead/Abandoned	Glaxo Wellcome Inc. 1997-09-19