TempaDOT TD Plus C

GUDID 20016944301077

TempaDOT Plus C single use clinical Thermometer with Rectal Sheath

MEDICAL INDICATORS INC

Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer
Primary Device ID20016944301077
NIH Device Record Key73060ae8-fe27-458f-9b55-caad028fa3d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempaDOT
Version Model Number5502R
Catalog NumberTD Plus C
Company DUNS030104165
Company NameMEDICAL INDICATORS INC
Device Count100
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound
Weight0.0022 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100016944301073 [Primary]
GS110016944301070 [Unit of Use]
GS120016944301077 [Package]
Contains: 00016944301073
Package: Case [1600 Units]
In Commercial Distribution

FDA Product Code

FQZThermometer, Clinical Color Change

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-23
Device Publish Date2021-05-29

On-Brand Devices [TempaDOT]

20016944301145TempaDOT C Non-Sterile Single use Clinical Thermometer
20016944301138TempaDOT F Non-Sterile Single use Clinical Thermometer
20016944301084TempaDOT C Sterile Single use Clinical Thermometer
20016944301077TempaDOT Plus C single use clinical Thermometer with Rectal Sheath
20016944301060TempaDOT Plus F single use Clinical Thermometer with Rectal Sheath
20016944301053TempaDOT Bulk F Single Use Clinical Thermometer
10016944301025TempaDOT F Sterile Single use Thermometer
20016944301039TempaDOT F Non-Sterile single use Clinical thermometer
20016944301022TempaDOT F Sterile Clinical single use thermometer
20016944301008TempaDOT Axillary F Single use thermometer

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