Physio Logic Accuflex Digital Thermometer - Red 016-629

GUDID 00057565972853

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 ID00057565972853
NIH Device Record Key5a4a9afc-6c6e-422f-803d-e511b87a30df
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhysio Logic Accuflex Digital Thermometer - Red
Version Model Number016-629
Catalog Number016-629
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100057565166290 [Primary]
GS100057565972761 [Package]
Package: Master Case [12 Units]
In Commercial Distribution
GS100057565972853 [Package]
Contains: 00057565166290
Package: Box [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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00057565972853 - Physio Logic Accuflex Digital Thermometer - Red2023-06-19Accuflex® 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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