AccessGUDID - DEVICE: Oxyband (00009235000007)

GUDID

Device Identifier (DI) Information

Brand Name: Oxyband
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2804000
Company Name: The Lighthouse For The Blind

Primary DI Number: 00009235000007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051731214 *Terms of Use

Device Description: Oxyband 7 X 9 Dressing

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62348	Wound therapy oxygenator dressing	A sterile wound cover designed to be used in conjunction with a wound therapy oxygenator to actively promote continuous diffusion of oxygen (CDO) in a wound bed to heal various types of wounds (e.g., arterial, venous, diabetic or pressure ulcers, skin grafts, burns, and/or postoperative or traumatic wounds). It is made of synthetic polymer materials and consists of an absorbent open-cell foam layer, an oxygen (O2) distribution foam layer, an occlusive layer to create an O2 rich environment, and integrated O2 tubing/connector. It may have an adhesive border and may be cut to conform to the wound. O2 delivery extension tubing may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043063	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd870672-2835-41c5-888a-e98b85e10d11
Public Version Date: October 13, 2021
Public Version Number: 1
DI Record Publish Date: October 05, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 877.774.4211
Email: OxyBandUS@semlerscientific.com

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