Genius 3 303013

GUDID 10884521738522

Tympanic Thermometer and Base

Cardinal Health, Inc.

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer
Primary Device ID10884521738522
NIH Device Record Key0e53585e-8ceb-4693-a49e-800a9968fbd4
Commercial Distribution Discontinuation2025-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenius 3
Version Model Number303013
Catalog Number303013
Company DUNS080935429
Company NameCardinal Health, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 61 Degrees Fahrenheit and 91 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *;
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521738522 [Primary]

FDA Product Code

FLLThermometer, electronic, clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-01-05
Device Publish Date2018-04-21

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