Pro Comfort Tempa Check 4-in-1 Infrared thermometer

GUDID 10850632007345

Medical thermometer for measuring ear/ forehead/ object temperature/ ambient temperature of human body via infrared rays emitted from the eardrum and skin surface. Measuring range: 32.0-42.9°C (89.6-109.2°F)

HOME AIDE DIAGNOSTICS, INC.

Intermittent electronic patient thermometer

• Primary Device ID: 10850632007345
• NIH Device Record Key: 3a1b8b9c-a3a4-4afe-9f48-2ae4649be625
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro Comfort Tempa Check 4-in-1 Infrared thermometer
• Version Model Number: 10059798
• Company DUNS: 783518983
• Company Name: HOME AIDE DIAGNOSTICS, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-915-0116
• Email: info@homeaide.us

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850632007348 [Primary]
GS1	10850632007345 [Package]; Contains: 00850632007348; Package: Inner Case [50 Units]; In Commercial Distribution
GS1	20850632007342 [Package]; Package: Outer Carton [2 Units]; In Commercial Distribution

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: 2020-03-06
• Device Publish Date: 2020-02-27

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