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OxySpur® lite Oxygen Diffusion Dressing

FDA UDI

Class II (US FDA UDI)

by Electrochemical Oxygen Concepts, Inc.

Identity

Trade Name
OxySpur® lite Oxygen Diffusion Dressing FDA UDI
Generic Name
Wound therapy oxygenator dressing FDA UDI
Device Name
OxySpur® lite Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are constructed with a non-adherent mesh layer directly adjacent to the wound, one lite absorbent hydrophilic foam layer with channels for oxygen distribution, covered by an occlusive film, and an adhesive border. The OxySpur® lite is to be used on wounds with minimal to low exudate, such as later in the wound healing cycle when wound exudate levels decrease. FDA UDI
Model / Reference
2" x 8" Adhesive FDA UDI
Description
OxySpur® lite Oxygen Diffusion Dressings are hydrophilic dressings designed for use with the OxyGeni® System in the management of wounds. The dressings are constructed with a non-adherent mesh layer directly adjacent to the wound, one lite absorbent hydrophilic foam layer with channels for oxygen distribution, covered by an occlusive film, and an adhesive border. The OxySpur® lite is to be used on wounds with minimal to low exudate, such as later in the wound healing cycle when wound exudate levels decrease. FDA UDI

Identifiers

Catalog Number
600014 FDA UDI
Primary DI / UDI-DI
00851404004107 FDA UDI
510(k) Number
K090681 FDA UDI
FDA Product Code
KPJ FDA UDI
GMDN Term
Wound therapy oxygenator dressing 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 dressing

OxySpur® lite Oxygen Diffusion Dressing 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 dressing.

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 5d2a31b8-fec3-4cdd-a000-a5bb1d3d62f6 35 fields · synced May 30, 2026