← Back to catalogue

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 4.5 X 5.5 Dressing FDA UDI
Model / Reference
1 FDA UDI
Description
Oxyband 4.5 X 5.5 Dressing FDA UDI

Identifiers

Primary DI / UDI-DI
00009235421772 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
The Lighthouse For the Blind, Inc.

Sources (1)

  • FDA UDI b78f53d6-2453-4fb1-b2d0-4bc49a49bb13 35 fields · synced May 31, 2026