Home GUDID 30357599801008 FreeStyle Libre 2
Primary DI 30357599801008
Brand FreeStyle Libre 2
Company ABBOTT DIABETES CARE INC
Model 72000
Catalog number 72000
Device description FreeStyle Libre 2 Flash Glucose Monitoring System Sensor
Published 2020-07-31
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name QLG Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30357599801008 Package GS1 1 In Commercial Distribution 00357599801007 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30357599801008 30357599801008 00357599801007 00357599801007 357599801007 0357599801007
GMDN Terms# Term, Definition table Term Definition Percutaneous glucose monitoring system An assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It consists of a sterile, electrochemical, percutaneously-inserted electrode that connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home or clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 36 Degrees Fahrenheit 82 Degrees Fahrenheit
Regulatory Flags# DUNS number 966390890 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00357599805012 FreeStyle Libre 2 ABBOTT DIABETES CARE INC QLG 2025-07-25 00357599803018 FreeStyle Libre 2 ABBOTT DIABETES CARE INC QLG 2025-07-25 00357599804015 FreeStyle Libre 2 ABBOTT DIABETES CARE INC QLG 2025-07-25 30357599805013 FreeStyle Libre 2 ABBOTT DIABETES CARE INC QLG 2025-07-25 30357599803019 FreeStyle Libre 2 ABBOTT DIABETES CARE INC QLG 2025-07-25 00357599840006 Libre App ABBOTT DIABETES CARE INC QLG 2024-12-17 00357599841003 Libre App ABBOTT DIABETES CARE INC QLG 2024-12-17 00850003506579 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-10-09 00850003506586 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-10-09 00850003506593 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-07-12 00850003506531 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506548 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506555 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506562 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506609 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506616 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506623 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506630 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506647 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506654 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506661 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506678 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506685 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-04-03 00850003506524 Bigfoot Unity Bigfoot Biomedical, Inc. QLG 2023-03-30 00357599816001 FreeStyle Libre 3 App ABBOTT DIABETES CARE INC QLG 2022-07-26 00357599817008 FreeStyle Libre 3 App ABBOTT DIABETES CARE INC QLG 2022-07-05 00357599818005 FreeStyle Libre 3 ABBOTT DIABETES CARE INC QLG 2022-06-23 00357599819002 FreeStyle Libre 3 ABBOTT DIABETES CARE INC QLG 2022-06-23 30357599818006 FreeStyle Libre 3 ABBOTT DIABETES CARE INC QLG 2022-06-23 30357599819003 FreeStyle Libre 3 ABBOTT DIABETES CARE INC QLG 2022-06-23
xx.xx