Advocate BMB Control Solutions High 005

GUDID 00894046001608

Advocate BMB Control Solutions High

DIABETIC SUPPLY OF SUNCOAST, INC.

Glucose IVD, control

• Primary Device ID: 00894046001608
• NIH Device Record Key: 5a9066d3-b20d-42e1-a86d-7c494f12c7ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advocate BMB Control Solutions High
• Version Model Number: 005
• Catalog Number: 005
• Company DUNS: 043081723
• Company Name: DIABETIC SUPPLY OF SUNCOAST, 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: false
• 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: true

Customer Support Contacts

• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com
• Phone: 8884693579
• Email: lhenry@pharmasupply.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894046001608 [Primary]
GS1	20894046001602 [Package]; Package: 005-C [1000 Units]; In Commercial Distribution

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-08-31
• Device Publish Date: 2016-08-19

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