FDA.reportPublic FDA data

Libre App

Primary DI
00357599841003
Brand
Libre App
Company
ABBOTT DIABETES CARE INC
Model
78746-01
Catalog number
78746-01
Device description
Libre IOS App US
Published
2024-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233537000FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.2024-04-23QBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00357599841003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00357599841003003575998410033575998410030357599841003

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
966390890
Device count
1

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
00357599880002InstinctABBOTT DIABETES CARE INCQBJ2025-09-22
30357599880003InstinctABBOTT DIABETES CARE INCQBJ2025-09-22
00386270004574Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004727Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004734Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004741Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004758Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004765Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00357599805012FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599820015FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-07-25
00357599835019FreeStyle Libre 2 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
00357599836016FreeStyle Libre 2 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
00357599842017FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-07-25
00357599803018FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599804015FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
30357599805013FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
30357599835010FreeStyle Libre 2 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
30357599836017FreeStyle Libre 2 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
30357599842018FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-07-25
00357599843014FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
00357599844011FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
30357599803019FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599821005FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-07-18
00357599821012FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-06-25
30357599821013FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-06-25
00386270005168Dexcom G7 iOS Watch AppDexcom, Inc.QBJ2025-03-17
00386270005175Dexcom G7 Wear OS Watch AppDexcom, Inc.QBJ2025-03-17
00357599840006Libre AppABBOTT DIABETES CARE INCQLG2024-12-17
00357599840006Libre AppABBOTT DIABETES CARE INCQBJ2024-12-17
00357599844004FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2024-07-16