SteriTec Green Card Bowie-Dick Test Starter Kit BD 116

GUDID 30814434020715

8 Kits containing 1 holder + 31 tests

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 30814434020715
• NIH Device Record Key: 9c922074-0781-43e3-9216-7374852ea269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriTec Green Card Bowie-Dick Test Starter Kit
• Version Model Number: BD 116
• Catalog Number: BD 116
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814434020714 [Primary]
GS1	10814434020711 [Package]; Contains: 00814434020714; Package: Box [30 Units]; In Commercial Distribution
GS1	20814434020718 [Package]; Contains: 10814434020711; Package: Kit [31 Units]; In Commercial Distribution
GS1	30814434020715 [Package]; Contains: 20814434020718; Package: Case [8 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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