Chemdye®

GUDID 07798164676836

Multivariable process indicator for monitoring Steam sterilization processes

TERRAGENE S.A.

Chemical/physical sterilization process indicator
Primary Device ID07798164676836
NIH Device Record Key1f5de0cb-4d0a-4c0c-b33e-97d85368d5ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameChemdye®
Version Model NumberCD29
Company DUNS970856911
Company NameTERRAGENE S.A.
Device Count250
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107798164673705 [Primary]
GS107798164676836 [Unit of Use]

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-01
Device Publish Date2022-03-24

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07798164676850Chemical Indicator strip for monitoring hydrogen peroxide sterilization processes.
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07798164678847Chemical indicator Bowie-Dick Test Pack with Warning Sheet.
07798164679295Bowie-Dick Test Cards with holder
07798164677871Bowie-Dick Test Card
07798375770224Bowie-Dick Test Sheet
07798164676805Multivariable process indicator for monitoring Ethylene Oxide sterilization processes
07798164676836Multivariable process indicator for monitoring Steam sterilization processes

Trademark Results [Chemdye]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHEMDYE
CHEMDYE
88059790 5697020 Live/Registered
Terragene S.A.
2018-07-31

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