PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red) 016-619

GUDID 00057565975120

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

A.M.G. Médicale Inc

Intermittent electronic patient thermometer
Primary Device ID00057565975120
NIH Device Record Key7f5428ba-3557-4170-a732-56c624e5c47d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)
Version Model Number016-619
Catalog Number016-619
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
GS100057565166191 [Primary]
GS100057565975120 [Package]
Contains: 00057565166191
Package: [50 Units]
In Commercial Distribution
GS100057565975137 [Package]
Package: [10 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)2023-06-19 Accuflex®Pro+ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections an
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