EPIFLO® 01-120-100010

GUDID 00855526003062

Transdermal Continuous O2 Therapy. Oxygen Concentrator

Ogenix

Wound therapy oxygenator, single-use

• Primary Device ID: 00855526003062
• NIH Device Record Key: cdf601ca-68c5-46f7-9a6e-1de9588b2296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIFLO®
• Version Model Number: 15-day
• Catalog Number: 01-120-100010
• Company DUNS: 829285464
• Company Name: Ogenix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2168390202
• Email: lcali@ogenix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855526003055 [Primary]
GS1	00855526003062 [Package]; Contains: 00855526003055; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120764

FDA Product Code

• KPJ: Chamber, Oxygen, Topical, Extremity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-07

On-Brand Devices [EPIFLO®]

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