PhysioLogic DigiPro+ 30 second Digital Oral Thermometer 016-625

GUDID 00057565166252

DigiPro+ ™ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. What’s more, DigiPro+™ utilizes a “real measurement” technology, which permits read after the beep if a higher temperature is later detected. Accurate within ± 0.1°C in the 35.5°C to 42°C range Displays in Celsius or Fahrenheit Response time: 30 seconds for oral readings Auto shut-off feature Memory recall / display of last reading Individually packaged, includes storage case

A.M.G. Médicale Inc

Intermittent electronic patient thermometer

• Primary Device ID: 00057565166252
• NIH Device Record Key: 599aaa5b-9ce3-45e1-bd64-ccd60bc53917
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhysioLogic DigiPro+ 30 second Digital Oral Thermometer
• Version Model Number: 016-625
• Catalog Number: 016-625
• Company DUNS: 207372814
• Company Name: A.M.G. Médicale 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00057565166252 [Package]; Contains: 00057565964568; Package: BOX [50 Units]; In Commercial Distribution
GS1	00057565964568 [Primary]
GS1	00057565986621 [Package]; Package: Master Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163518

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: 2023-06-19
• Device Publish Date: 2023-06-09

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