Advocate BMB Control Solutions Low BMB003

GUDID 00894046001585

Advocate BMB Control Solutions Low

DIABETIC SUPPLY OF SUNCOAST, INC.

Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control
Primary Device ID00894046001585
NIH Device Record Key4213e192-00b3-4793-9359-dd7f83ea964a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvocate BMB Control Solutions Low
Version Model NumberBMB003
Catalog NumberBMB003
Company DUNS043081723
Company NameDIABETIC SUPPLY OF SUNCOAST, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com
Phone1-888-469-3579
Emaillhenry@pharmasupply.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100894046001585 [Primary]
GS120894046001589 [Package]
Package: 003-C [1000 Units]
In Commercial Distribution

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-08-31
Device Publish Date2016-08-19

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