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OxyGeni® Dual Port cannula

FDA UDI

Class II (US FDA UDI)

by Electrochemical Oxygen Concepts, Inc.

Identity

Trade Name
OxyGeni® Dual Port cannula FDA UDI
Generic Name
Wound therapy oxygenator tubing FDA UDI
Device Name
The OxyGeni® Dual Port cannula is an optional accessory of the OxyGeni® System. It consist of two lengths of flexible tubing extensions Sleeved together with connectors at both ends intended to connect multiple OxyGeni® Oxygen Generators to multiple proprietary Oxygen Diffusion Dressings to deliver oxygen (O2) to a wound bed(s) during continuous diffusion of oxygen (CDO™) therapy. It may be secured to the skin using medical tape. FDA UDI
Model / Reference
610000 FDA UDI
Description
The OxyGeni® Dual Port cannula is an optional accessory of the OxyGeni® System. It consist of two lengths of flexible tubing extensions Sleeved together with connectors at both ends intended to connect multiple OxyGeni® Oxygen Generators to multiple proprietary Oxygen Diffusion Dressings to deliver oxygen (O2) to a wound bed(s) during continuous diffusion of oxygen (CDO™) therapy. It may be secured to the skin using medical tape. FDA UDI

Identifiers

Primary DI / UDI-DI
00851404004077 FDA UDI
510(k) Number
K090681 FDA UDI
FDA Product Code
KPJ FDA UDI
GMDN Term
Wound therapy oxygenator tubing 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

No

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 tubing

OxyGeni® Dual Port cannula by Electrochemical Oxygen Concepts, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound therapy oxygenator tubing.

Cleared under the same submission

K090681 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Electrochemical Oxygen Concepts, Inc.

Sources (1)

  • FDA UDI 327fde05-18a5-440d-8da3-596718ee91c9 35 fields · synced Jun 8, 2026