LIVIN

GUDID 00850020077090

LIVIN WELLNESS, LLC

Infrared patient thermometer, skin

• Primary Device ID: 00850020077090
• NIH Device Record Key: 56df9bbf-a290-474b-91f0-7d06c1671174
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIVIN
• Version Model Number: FC-IR1202
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850020077090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181215

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2020-12-28
• Device Publish Date: 2020-12-20

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)