ACCUFLEXPRO+ RECTAL THERMOMETER (RED) 016-649

GUDID 00057565973461

Accuflex®Pro+ 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 provides quick and accurate readings healthcare professionals can count on. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds for oral readings Washable for easy cleaning Gentle-flex tip for patient comfort Easy to use with large screen for better nighttime visibility Display in Celsius or Fahrenheit 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

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• Primary Device ID: 00057565973461
• NIH Device Record Key: 320c9f52-a5c8-4cb7-be84-55a8bc397ac5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUFLEXPRO+ RECTAL THERMOMETER (RED)
• Version Model Number: 016-649
• Catalog Number: 016-649
• 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	00057565166498 [Primary]
GS1	00057565973461 [Package]; Contains: 00057565166498; Package: Box [12 Units]; In Commercial Distribution
GS1	00057565973478 [Package]; Package: Master Case [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

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• 00057565973461 - ACCUFLEXPRO+ RECTAL THERMOMETER (RED): 2023-06-19Accuflex®Pro+ 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 provides quick and accurate readings healthcare professionals can count on. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds for oral readings Washable for easy cleaning Gentle-flex tip for patient comfort Easy to use with large screen for better nighttime visibility Display in Celsius or Fahrenheit 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
• 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