SteriTec Dry Heat Indicator Labels CI 113, CI 113/ITL

GUDID 20814434020497

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 20814434020497
• NIH Device Record Key: 672f435a-375c-4c17-97b0-af231aadb30e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriTec Dry Heat Indicator Labels
• Version Model Number: CI 113
• Catalog Number: CI 113, CI 113/ITL
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814434020493 [Primary]
GS1	10814434020490 [Package]; Contains: 00814434020493; Package: Box [1000 Units]; In Commercial Distribution
GS1	20814434020497 [Package]; Contains: 10814434020490; Package: Case [10 Units]; In Commercial Distribution
GS1	30814434020494 [Package]; Contains: 00814434020493; Package: Box [1000 Units]; In Commercial Distribution
GS1	40814434020491 [Package]; Contains: 30814434020494; Package: Case [10 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: 3
• Public Version Date: 2018-05-22
• Device Publish Date: 2016-09-23

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