Getinge Assured S.M.A.R.T. Pack II Bowie-Dick Test Pack 61301605554

GUDID 00814434020257

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 00814434020257
• NIH Device Record Key: 110dc60d-36a1-4b18-999a-3bc338321f9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge Assured S.M.A.R.T. Pack II Bowie-Dick Test Pack
• Version Model Number: 61301605554
• Catalog Number: 61301605554
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814434020257 [Primary]
GS1	10814434020254 [Package]; Package: Case [30 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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