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EPIFLO® oxygen delivery cannula

FDA UDI

Class II (US FDA UDI)

by Ogenix

Identity

Trade Name
EPIFLO® oxygen delivery cannula FDA UDI
Generic Name
Wound therapy oxygenator, single-use FDA UDI
Device Name
Oxygen delivery cannula for use with EPIFLO device only. FDA UDI
Model / Reference
01-110-100002 FDA UDI
Description
Oxygen delivery cannula for use with EPIFLO device only. FDA UDI

Identifiers

Primary DI / UDI-DI
00855526003024 FDA UDI
510(k) Number
K120764 FDA UDI
FDA Product Code
KPJ FDA UDI
GMDN Term
Wound therapy oxygenator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wound therapy oxygenator, single-use

EPIFLO® oxygen delivery cannula by Ogenix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound therapy oxygenator, single-use.

Cleared under the same submission

K120764 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ogenix

Sources (1)

  • FDA UDI 9aed04a7-a13d-4a12-aba1-6c4be777794e 35 fields · synced Jun 1, 2026