Famidoc

GUDID 00854314007121

Non-Contact Infrared Thermometer

FAMIDOC USA, INC.

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• Primary Device ID: 00854314007121
• NIH Device Record Key: 477758e9-8ebd-43f0-adf2-b6711c018fb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Famidoc
• Version Model Number: FDIR-V22
• Company DUNS: 080370811
• Company Name: FAMIDOC USA, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00854314007121 [Primary]
GS1	10854314007128 [Package]; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113761

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-29

On-Brand Devices [Famidoc]

• 00854314007527: Multi-function TENS&EMS Dual pad device
• 00854314007510: ABDOMINAL FITNESS BELT
• 00854314007503: Pain Relief Plaster
• 00854314007350: DIGITAL CLINICAL THERMOMETER
• 00854314007343: DIGITAL CLINICAL THERMOMETER
• 00854314007336: DIGITAL CLINICAL THERMOMETER
• 00854314007329: DIGITAL CLINICAL THERMOMETER
• 00854314007312: DIGITAL CLINICAL THERMOMETER
• 00854314007305: DIGITAL CLINICAL THERMOMETER
• 00854314007121: Non-Contact Infrared Thermometer
• 00854314007114: Non-contact Infrared thermometer
• 00854314007107: Infrared Ear Thermometer
• 00854314007084: FDCO-V11
• 00854314007015: Metal Comb
• 00854314007008: Elecronic Comb