Home GUDID 07798164672135 Chemdye®
Primary DI 07798164672135
Brand Chemdye®
Company TERRAGENE S.A.
Model CD40
Device description Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.
Published 2022-03-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07798164672135 Primary GS1 0 07798164676843 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07798164672135 07798164672135 7798164672135 07798164676843 07798164676843 7798164676843
GMDN Terms# Term, Definition table Term Definition Chemical/physical sterilization process indicator A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 30 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 970856911 Device count 500 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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