FDA.reportPublic FDA data

Oxyband

Primary DI
00009235421772
Brand
Oxyband
Company
The Lighthouse For The Blind
Model
1
Device description
Oxyband 4.5 X 5.5 Dressing
Published
2021-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043063000OXYBAND WOUND DRESSINGOxyband Technologies, Inc.2005-03-24NAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00009235421772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00009235421772000092354217720092354217720009235421772

GMDN Terms#

Term, Definition table
TermDefinition
Wound therapy oxygenator dressingA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877.774.4211OxybandUS@semlerscientific.com

Regulatory Flags#

DUNS number
051731214
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00009235421796LHB IndustriesUltraFlex Small w/ wipe22040372021-10-01
00009235421802LHB IndustriesUltra Flex Small22040382021-10-01
00009235421819LHB IndustriesUltra Flex Medium w/ wipes22040392021-10-01
00009235421826LHB IndustriesUltra Flex Medium22040402021-10-01
00009235421833LHB IndustriesUltra Flex Intermed w/ wipe220400412021-10-01
00009235421840LHB IndustriesUltra Flex Intermed22040422021-10-01
00009235421857LHB IndustriesUltra Flex Large w/wipe22040432021-10-01
00009235421864LHB IndustriesUltra Flex Large22040442021-10-01
00009235421871LHB IndustriesUltra Flex XL w/wipe22040452021-10-01
00009235421888LHB IndustriesUltra Flex XL22040462021-10-01
00009235421895LHB IndustriesWide Band Small22040502021-10-01
00009235421901LHB IndustriesWide Band Medium220400512021-10-01
00009235421918LHB IndustriesWide Band Intermed22040522021-10-01
00009235421925LHB IndustriesWide Band Large 22040532021-10-01
00009235421932LHB IndustriesWide Band Large w/ wipe2204053-W2021-10-01
00009235000007Oxyband128040002021-10-05

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Primary DI, Brand, Company table
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