Genius 2

GUDID 00697077002596

Amico Diagnostic Incorporated

Infrared patient thermometer, ear

• Primary Device ID: 00697077002596
• NIH Device Record Key: 0101bdc9-a468-44a9-bc8d-cfd4d1d097c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genius 2
• Version Model Number: TT-F-IR
• Company DUNS: 203163290
• Company Name: Amico Diagnostic Incorporated
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00697077002596 [Primary]

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Genius 2]

• 00697077001933: TT-D-IR
• 00697077001926: TT-A-IR
• 00697077002596: TT-F-IR