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Oxyband

FDA UDI

Class U (US FDA UDI)

by The Lighthouse For the Blind, Inc.

Identity

Trade Name
Oxyband FDA UDI
Generic Name
Wound therapy oxygenator dressing FDA UDI
Device Name
Oxyband 7 X 9 Dressing FDA UDI
Model / Reference
1 FDA UDI
Description
Oxyband 7 X 9 Dressing FDA UDI

Identifiers

Catalog Number
2804000 FDA UDI
Primary DI / UDI-DI
00009235000007 FDA UDI
510(k) Number
K043063 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Wound therapy oxygenator dressing FDA UDI

Classification

Device Class
U 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

No

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

Oxyband by The Lighthouse For the Blind, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound therapy oxygenator dressing.

Cleared under the same submission

K043063 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
The Lighthouse For the Blind, Inc.

Sources (1)

  • FDA UDI fd870672-2835-41c5-888a-e98b85e10d11 36 fields · synced May 30, 2026