FreeStyle Libre 71536

GUDID 30357599000197

FreeStyle Libre Sensor Kit

ABBOTT DIABETES CARE INC

Percutaneous glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID30357599000197
NIH Device Record Key93f04e28-de0d-4be6-b190-cb59f9b53d0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Libre
Version Model Number71536
Catalog Number71536
Company DUNS966390890
Company NameABBOTT DIABETES CARE INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100357599000196 [Primary]
GS130357599000197 [Package]
Contains: 00357599000196
Package: Case [24 Units]
In Commercial Distribution
NDC/NHRIC57599-0000-19 [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 Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-20

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30357599000203FreeStyle Libre Sensor Kit
30357599000197FreeStyle Libre Sensor Kit

Trademark Results [FreeStyle Libre]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE LIBRE
FREESTYLE LIBRE
87429782 5531286 Live/Registered
Abbott Diabetes Care Inc.
2017-04-28
FREESTYLE LIBRE
FREESTYLE LIBRE
87429781 5500523 Live/Registered
Abbott Diabetes Care Inc.
2017-04-28
FREESTYLE LIBRE
FREESTYLE LIBRE
86063019 not registered Dead/Abandoned
Abbott Diabetes Care Inc.
2013-09-12

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