EPIFLO® 01-130-100010

GUDID 00855526003086

Wound therapy oxygenator, single-use

Primary Device ID	00855526003086
NIH Device Record Key	14a75319-35d1-4a1f-b934-a6ca2932ad23
Commercial Distribution Status	In Commercial Distribution
Brand Name	EPIFLO®
Version Model Number	28-day
Catalog Number	01-130-100010
Company DUNS	829285464
Company Name	Ogenix
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
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	00855526003079 [Primary]
GS1	00855526003086 [Package] Contains: 00855526003079 Package: Box [10 Units] In Commercial Distribution

KPJ	Chamber, Oxygen, Topical, Extremity

Steralize Prior To Use	false
Device Is Sterile	true

00855526003062	Transdermal Continuous O2 Therapy. Oxygen Concentrator
00855526003086	Transdermal Continuous O2 Therapy Oxygen Concentrator and 6 Cannulas

Mark Image Registration \| Serial	Company Trademark Application Date
EPIFLO 76551026 3060687 Live/Registered	NEOGENIX, LLC 2003-09-22