Oxyband

GUDID 00009235421772

Oxyband 4.5 X 5.5 Dressing

The Lighthouse For The Blind

Wound therapy oxygenator dressing

• Primary Device ID: 00009235421772
• NIH Device Record Key: b78f53d6-2453-4fb1-b2d0-4bc49a49bb13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxyband
• Version Model Number: 1
• Company DUNS: 051731214
• Company Name: The Lighthouse For The Blind
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com
• Phone: 877.774.4211
• Email: OxybandUS@semlerscientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00009235421772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043063

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-13
• Device Publish Date: 2021-10-05

On-Brand Devices [Oxyband]

• 00009235421772: Oxyband 4.5 X 5.5 Dressing
• 00009235000007: Oxyband 7 X 9 Dressing