ACCUFLEXPRO+ ORAL THERMOMETER (BLUE) 016-648

GUDID 00057565973447

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

Intermittent electronic patient thermometer
Primary Device ID00057565973447
NIH Device Record Keyce5d18e0-8410-4fc9-9924-83c098da500e
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCUFLEXPRO+ ORAL THERMOMETER (BLUE)
Version Model Number016-648
Catalog Number016-648
Company DUNS207372814
Company NameA.M.G. Médicale Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100057565166481 [Primary]
GS100057565973447 [Package]
Contains: 00057565166481
Package: Box [12 Units]
In Commercial Distribution
GS100057565973454 [Package]
Package: Master Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

Devices Manufactured by A.M.G. Médicale Inc

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00057565973447 - ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)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
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