Physio Logic Accuflex Digital Thermometer 016-628

GUDID 00057565972846

Accuflex® 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. This digital thermometer is easy to use and provides fast readings. Most importantly, Accuflex is reliable and accurate for patients of all ages. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds Washable for easy cleaning Gentle-flex tip for patient comfort Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal

A.M.G. Médicale Inc

Intermittent electronic patient thermometer

• Primary Device ID: 00057565972846
• NIH Device Record Key: daeeb53a-9ac9-48e4-8dad-afb19f8cde46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Physio Logic Accuflex Digital Thermometer
• Version Model Number: 016-628
• Catalog Number: 016-628
• 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: 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	00057565166283 [Primary]
GS1	00057565972754 [Package]; Package: Master Case [12 Units]; In Commercial Distribution
GS1	00057565972846 [Package]; Contains: 00057565166283; Package: [12 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

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• 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: 2023-06-19Accuflex® 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. This digital thermometer is easy to use and provides fast readings. Most importantly, Accuflex is reliable and accurate for patients of all ages. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds Washable for easy cleaning Gentle-flex tip for patient comfort Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal
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• 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