EPIFLO®

Basic Information

• Brand Name: EPIFLO®
• Primary DI: 00855526003055
• Version / Model: 15-day
• Catalog Number: 01-120-100010
• Company Name: Ogenix
• Labeler DUNS: 829285464
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: cdf601ca-68c5-46f7-9a6e-1de9588b2296

Device Description

Transdermal Continuous O2 Therapy. Oxygen Concentrator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	878.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59124	Wound therapy oxygenator, single-use	A wearable, battery-powered device designed to actively promote continuous diffusion of oxygen (CDO) in a wound to help heal various types of wounds (e.g., arterial, venous, diabetic or pressure ulcers; burns; postoperative or traumatic wounds). It is intended to concentrate oxygen (O2) from ambient air and pump it through an included sterile delivery tube intended to be secured to the wound bed, which is typically covered by an absorbent and occlusive dressing. It is intended to be used continuously over a prescribed period, being discarded and replaced along with the dressing as required. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00855526003062	GS1	Box	10	In Commercial Distribution
Primary	00855526003055	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120764	000