EPIFLO® oxygen delivery cannula

GUDID 00855526003024

Oxygen delivery cannula for use with EPIFLO device only.

Ogenix

Wound therapy oxygenator, single-use

• Primary Device ID: 00855526003024
• NIH Device Record Key: 9aed04a7-a13d-4a12-aba1-6c4be777794e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIFLO® oxygen delivery cannula
• Version Model Number: 01-110-100002
• 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: false
• Manufacturing Date: false
• 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
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com
• Phone: 7817026732
• Email: lcali@ogenix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855526003024 [Primary]

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

Devices Manufactured by Ogenix

• 00855526003086 - EPIFLO®: 2023-06-16 Transdermal Continuous O2 Therapy Oxygen Concentrator and 6 Cannulas
• 00855526003024 - EPIFLO® oxygen delivery cannula: 2018-07-06Oxygen delivery cannula for use with EPIFLO device only.
• 00855526003024 - EPIFLO® oxygen delivery cannula: 2018-07-06 Oxygen delivery cannula for use with EPIFLO device only.
• 00855526003062 - EPIFLO®: 2018-07-06 Transdermal Continuous O2 Therapy. Oxygen Concentrator