FreeStyle Libre 14 day 71938

GUDID 57599-0002-00

FreeStyle Libre 14 day Reader Kit US

ABBOTT DIABETES CARE INC

Percutaneous glucose monitoring system
Primary Device ID57599-0002-00
NIH Device Record Key362f7c3e-a17f-4f10-959c-49bcb5e6ad4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Libre 14 day
Version Model Number71938
Catalog Number71938
Company DUNS966390890
Company NameABBOTT DIABETES CARE INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100357599002008 [Primary]
GS130357599002009 [Package]
Contains: 00357599002008
Package: [4 Units]
In Commercial Distribution
NDC/NHRIC57599-0002-00 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-22
Device Publish Date2019-08-14

On-Brand Devices [FreeStyle Libre 14 day]

30357599001026FreeStyle Libre 14 day Sensor Kit NFRS
30357599001019FreeStyle Libre 14 day Sensor Kit
30357599002009FreeStyle Libre 14 day Reader Kit US
30357599000975FreeStyle Libre 14 day Reader Kit US, NFRS
30357599000982FreeStyle Libre 14 day Reader Kit US DOD
57599-0002-00FreeStyle Libre 14 day Reader Kit US
57599-0000-97FreeStyle Libre 14 day Reader Kit US

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