Advocate Redi-Code+ Blood Glucose Meter, Speaking, Kit BMB-001SK

GUDID 10894046001087

Advocate Redi-Code+ Blood Glucose Meter, Speaking, Kit

DIABETIC SUPPLY OF SUNCOAST, INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use
Primary Device ID10894046001087
NIH Device Record Key8ed8d2b5-3303-47e2-9196-4bc34bca4b1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvocate Redi-Code+ Blood Glucose Meter, Speaking, Kit
Version Model NumberBMB-001SK
Catalog NumberBMB-001SK
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8884693579
Emaillhenry@pharmasupply.com
Phone8884693579
Emaillhenry@pharmasupply.com
Phone8884693579
Emaillhenry@pharmasupply.com
Phone8884693579
Emaillhenry@pharmasupply.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling 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
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling 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
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling 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
Storage Environment Atmospheric PressureBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling 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
GS100894046001080 [Primary]
GS100894046001080 [Primary]
GS100894046001080 [Primary]
GS100894046001080 [Primary]
GS110894046001087 [Package]
Contains: 00894046001080
Package: BMB-001SK-C [50 Units]
In Commercial Distribution
GS110894046001087 [Package]
Contains: 00894046001080
Package: BMB-001SK-C [50 Units]
In Commercial Distribution
GS110894046001087 [Package]
Contains: 00894046001080
Package: BMB-001SK-C [50 Units]
In Commercial Distribution
GS110894046001087 [Package]
Contains: 00894046001080
Package: BMB-001SK-C [50 Units]
In Commercial Distribution

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter
NBWSystem, Test, Blood Glucose, Over The Counter
NBWSystem, Test, Blood Glucose, Over The Counter
NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-11-10
Device Publish Date2016-08-19

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