OxyTyke™ OT-1025-8

GUDID 00620974000495

Vortex oxygen face mask

Primary Device ID	00620974000495
NIH Device Record Key	c89907e1-c8cf-4de3-b6a7-02f2d78798b4
Commercial Distribution Status	In Commercial Distribution
Brand Name	OxyTyke™
Version Model Number	OT-1025-8
Catalog Number	OT-1025-8
Company DUNS	246848147
Company Name	Southmedic Incorporated
Device Count	25
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	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	00620974000495 [Unit of Use]
GS1	10620974000492 [Primary]

BYG	MASK, OXYGEN

Steralize Prior To Use	false
Device Is Sterile	false

10620974000522	OxyTyke Nebulizer Kit
00620974000501	OxyTyke Non PVC with 7ft tubing
00620974000495	OxyTyke Pediatric Mask with 7ft tubing non-painted