ARC InstaTemp Non-Touch Infrared Thermometer

GUDID 05391525574011

The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinical setting to measure temperature in infants and adults.

ARC DEVICES USA INC

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• Primary Device ID: 05391525574011
• NIH Device Record Key: 2e1cd61d-21b6-4b0c-b19c-303200393f8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARC InstaTemp Non-Touch Infrared Thermometer
• Version Model Number: 401
• Company DUNS: 079758824
• Company Name: ARC DEVICES 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: 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525574011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152905

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: 2020-05-21
• Device Publish Date: 2017-03-31

On-Brand Devices [ARC InstaTemp Non-Touch Infrared Thermometer]

• 05391525574014: The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinic
• 05391525574011: The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinic