FreeStyle Libre 3 72078

GUDID 30357599821013

FreeStyle Libre 3 Continuous Glucose Monitoring System Reader

ABBOTT DIABETES CARE INC

Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID30357599821013
NIH Device Record Key4e8c3430-68a4-4130-9979-691c9455e270
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Libre 3
Version Model Number72078
Catalog Number72078
Company DUNS966390890
Company NameABBOTT DIABETES CARE INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100357599821012 [Primary]
GS130357599821013 [Package]
Contains: 00357599821012
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBJIntegrated Continuous Glucose Monitoring system, factory calibrated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-03
Device Publish Date2025-06-25

On-Brand Devices [FreeStyle Libre 3]

30357599819003FreeStyle Libre 3 Sensor Kit NFRS
30357599818006FreeStyle Libre 3 Sensor Kit US
57599-0820-00FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
30357599842001FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
30357599821013FreeStyle Libre 3 Continuous Glucose Monitoring System Reader

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