ARC InstaTemp Infrared Thermometer

GUDID 00853524006011

InstaTemp Digital Non-Touch Thermometer is intended to be used to measure temperature in infants and adults. The InstaTemp can be used in the home or

ARC DEVICES USA INC

Infrared patient thermometer, skin

• Primary Device ID: 00853524006011
• NIH Device Record Key: f3780cd3-08f0-4224-839d-05148267103c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARC InstaTemp Infrared Thermometer
• Version Model Number: 601
• 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	00853524006011 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-03-30

On-Brand Devices [ARC InstaTemp Infrared Thermometer]

• 00853524006023: InstaTemp Digital Non-Touch Infrared Thermometer intended to be used to measure temperature in i
• 00853524006011: InstaTemp Digital Non-Touch Thermometer is intended to be used to measure temperature in infants
• 00853524006009: InstaTemp Digital Non-Touch Infrared Thermometer is intended to be used to measure temperature i
• 00853524006016: InstaTemp Digital Non-Touch Thermometer is intended to be used to measure temperature in infants