SteriTec Cross-Checks CI 107/US

GUDID 20814434020084

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 20814434020084
• NIH Device Record Key: 7a0dc22a-a25f-4717-a5e6-94baba9bb525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriTec Cross-Checks
• Version Model Number: CI 107/US
• Catalog Number: CI 107/US
• Company DUNS: 622223196
• Company Name: STERITEC PRODUCT MFG. CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814434020080 [Primary]
GS1	10814434020087 [Package]; Contains: 00814434020080; Package: Bag [250 Units]; In Commercial Distribution
GS1	20814434020084 [Package]; Contains: 10814434020087; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

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• 10814434021640 - Getinge Assured Green Tape 1": 2022-06-17
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• 10732224109265 - Crosstex International: 2020-05-06 Sure Check Strip
• 20814434020619 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 13cm: 2019-11-08
• 20814434020626 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm: 2019-11-08