Oxyband

GUDID 00009235421772

Oxyband 4.5 X 5.5 Dressing

The Lighthouse For The Blind

Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing Wound therapy oxygenator dressing 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