FDA.reportPublic FDA data

FreeStyle Libre 2

Primary DI
30357599803019
Brand
FreeStyle Libre 2
Company
ABBOTT DIABETES CARE INC
Model
71953-01
Catalog number
71953-01
Device description
FreeStyle Libre 2 Flash Glucose Monitoring System Reader
Published
2025-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QLGIntegrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30357599803019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3035759980301930357599803019

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial fluid glucose monitoring system, electrochemicalAn assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically 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 and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)632-8658xx@xx.xx

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00357599835019FreeStyle Libre 2 Plus78747787472025-07-25
00357599836016FreeStyle Libre 2 Plus78749787492025-07-25
00357599880002Instinct78893788932025-09-22
00357599843014FreeStyle Libre 3 Plus78769787692025-07-25
00357599844011FreeStyle Libre 3 Plus78768787682025-07-25
00357599850005Lingo78782-0178782-012025-11-17
00357599820015FreeStyle Libre 372079720792025-07-25
00357599821012FreeStyle Libre 372078720782025-06-25
00357599842017FreeStyle Libre 378754787542025-07-25
00357599833008Abbott78632786322023-01-20
00357599001025FreeStyle Libre 14 day71939719392018-10-10
30357599880003Instinct78893788932025-09-22
00357599803018FreeStyle Libre 271953719532025-07-25
00357599805012FreeStyle Libre 271951719512025-07-25
00357599804015FreeStyle Libre 271952719522025-07-25
30357599805013FreeStyle Libre 271951719512025-07-25
30357599820016FreeStyle Libre 372079720792025-07-25
30357599835010FreeStyle Libre 2 Plus78747787472025-07-25
30357599836017FreeStyle Libre 2 Plus78749787492025-07-25
30357599842018FreeStyle Libre 378754787542025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00357599805012FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599803018FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599804015FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
30357599805013FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599840006Libre AppABBOTT DIABETES CARE INCQLG2024-12-17
00357599841003Libre AppABBOTT DIABETES CARE INCQLG2024-12-17
00850003506579Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-10-09
00850003506586Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-10-09
00850003506593Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-07-12
00850003506531Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506548Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506555Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506562Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506609Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506616Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506623Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506630Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506647Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506654Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506661Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506678Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506685Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506524Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-03-30
00357599816001FreeStyle Libre 3 AppABBOTT DIABETES CARE INCQLG2022-07-26
00357599817008FreeStyle Libre 3 AppABBOTT DIABETES CARE INCQLG2022-07-05
00357599818005FreeStyle Libre 3ABBOTT DIABETES CARE INCQLG2022-06-23
00357599819002FreeStyle Libre 3ABBOTT DIABETES CARE INCQLG2022-06-23
30357599818006FreeStyle Libre 3ABBOTT DIABETES CARE INCQLG2022-06-23
30357599819003FreeStyle Libre 3ABBOTT DIABETES CARE INCQLG2022-06-23
00357599809003FreeStyle Libre 2 AppABBOTT DIABETES CARE INCQLG2021-12-14