Oxy2Mask™ OM-1425-8

GUDID 00620974003540

Vortex oxygen face mask

Primary Device ID	00620974003540
NIH Device Record Key	87830159-5585-4c0e-b102-f26a2e775a44
Commercial Distribution Status	In Commercial Distribution
Brand Name	Oxy2Mask™
Version Model Number	OM-1425-8
Catalog Number	OM-1425-8
Company DUNS	246848147
Company Name	Southmedic Incorporated
Device Count	25
DM Exempt	true
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	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00620974003540 [Unit of Use]
GS1	10620974003547 [Primary]

BYG	MASK, OXYGEN

Steralize Prior To Use	false
Device Is Sterile	false

00620974003557	O2 Plus Mask with ear elastics
00620974003540	O2 Adult Mask with ear elastics
00620974003533	O2 Plus Mask with 14ft tubing
00620974003526	O2 Adult Mask with 14ft tubing
00620974003519	O2 Kid Mask with 14ft tubing