PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue) 016-618

GUDID 00057565975106

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 Convenient colour codes: Blue for oral (016-618), Red for rectal (016-619) and White for oral, rectal or underarm (016-625)

A.M.G. Médicale Inc

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 00057565975106
• NIH Device Record Key: 6e87a89a-a520-4e4b-a464-1f29e8abd9c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue)
• Version Model Number: 016-618
• Catalog Number: 016-618
• 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	00057565166184 [Primary]
GS1	00057565975106 [Package]; Contains: 00057565166184; Package: Box [50 Units]; In Commercial Distribution
GS1	00057565975113 [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

Devices Manufactured by A.M.G. Médicale Inc

• 00057565976042 - FeverScan Fever Indicators by Physio Logic: 2023-06-21 Fever Scan fever indicators are convenient, fast, and effective in monitoring fever. They indicate temperature in 1 degree Celsi
• 00775757154251 - ProActive Alevia 2 in 1 TENS: 2023-06-20 The TENS 2-in-1 Physiotherapy Alevia™ by ProActive™ is a 2-in-1 (TENS and EMS) device that gives you the ability to fully cu
• 00057565975106 - PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue): 2023-06-19DigiPro+ ™ 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 Convenient colour codes: Blue for oral (016-618), Red for rectal (016-619) and White for oral, rectal or underarm (016-625)
• 00057565975106 - PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue): 2023-06-19 DigiPro+ ™ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and
• 00057565975120 - PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red): 2023-06-19 DigiPro+ ™ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and
• 00057565972846 - Physio Logic Accuflex Digital Thermometer: 2023-06-19 Accuflex® single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and ma
• 00057565972853 - Physio Logic Accuflex Digital Thermometer - Red: 2023-06-19 Accuflex® single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and ma
• 00057565973447 - ACCUFLEXPRO+ ORAL THERMOMETER (BLUE): 2023-06-19 Accuflex®Pro+ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections an
• 00057565973461 - ACCUFLEXPRO+ RECTAL THERMOMETER (RED): 2023-06-19 Accuflex®Pro+ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections an