LIVIN

GUDID 00850020077052

LIVIN WELLNESS, LLC

Pulse oximeter, battery-powered

• Primary Device ID: 00850020077052
• NIH Device Record Key: dd238556-6141-4c4f-a000-1f45e36ebb19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIVIN
• Version Model Number: FO0920A
• Company DUNS: 117667958
• Company Name: LIVIN WELLNESS, LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850020077052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063641

FDA Product Code

• DQA: Oximeter
• PGJ: Oximeter, Wellness

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-03
• Device Publish Date: 2020-11-25

On-Brand Devices [LIVIN]

• 00850020077052: FO0920A
• 00850020077090: FC-IR1202
• 00850020077151: Fingertip Pulse Oximeter
• 00850020077137: LIVIN Health Body Composition & Heart Health Smart Scale (White-Silver)
• 00850020077120: LIVIN Health Body Composition & Heart Health Smart Scale (Black-Gold)