SteriTec Cross-Checks EO CI 106, CI 106/ITL

GUDID 40814434020071

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator
Primary Device ID40814434020071
NIH Device Record Keyb7a91265-8c68-4a6a-bcd4-b1d51cdbf54d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriTec Cross-Checks EO
Version Model NumberCI 106
Catalog NumberCI 106, CI 106/ITL
Company DUNS622223196
Company NameSTERITEC PRODUCT MFG. CO., 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020073 [Primary]
GS110814434020070 [Package]
Contains: 00814434020073
Package: Bag [250 Units]
In Commercial Distribution
GS120814434020077 [Package]
Contains: 10814434020070
Package: Case [24 Units]
In Commercial Distribution
GS130814434020074 [Package]
Contains: 00814434020073
Package: Bag [250 Units]
In Commercial Distribution
GS140814434020071 [Package]
Contains: 30814434020074
Package: Case [24 Units]
In Commercial Distribution

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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10732224109265 - Crosstex International2020-05-06 Sure Check Strip
20814434020619 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 13cm2019-11-08
20814434020626 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm2019-11-08

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