FDA.reportPublic FDA data

FreeStyle Libre

Primary DI
00357599000479
Brand
FreeStyle Libre
Company
ABBOTT DIABETES CARE INC
Model
71527
Catalog number
71527
Device description
FreeSyle Libre Software CD
Published
2017-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHVContinuous glucose monitor retrospective data analysis software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHVContinuous Glucose Monitor Retrospective Data Analysis SoftwareClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30357599000470PackageGS18In Commercial Distribution
00357599000479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3035759900047030357599000470
00357599000479003575990004793575990004790357599000479

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Contacts#

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

Regulatory Flags#

DUNS number
966390890
Device count
1
Premarket exempt
true
Lot or batch
true

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
B553202311OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202312OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202313OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202406OTC0Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2025-12-09
10385083000152Omnipod Discover Insulet CorporationPHV2025-12-04
B553202301OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202302OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202303OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202257OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2025-05-29
00763000984755CareLink™ PersonalMEDTRONIC MINIMED, INC.PHV2025-01-02
00763000984762CareLink™ ClinicMEDTRONIC MINIMED, INC.PHV2025-01-02
B553202057OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2024-12-27
00850018992435Sugarmate, iOS Mobile ApplicationSugarmate, LLCPHV2023-09-06
00850018992602Sugarmate, Mac Glance ApplicationSugarmate, LLCPHV2023-09-06
00850018992619Sugarmate, Web ApplicationSugarmate, LLCPHV2023-09-06
00850018992626Sugarmate, Alexa Skill ApplicationSugarmate, LLCPHV2023-09-06
00850003506517Bigfoot Unity ReportBigfoot Biomedical, Inc.PHV2023-07-12
00389152106113Tandem SourceTandem Diabetes Care, Inc.PHV2023-06-20
07290017735023endo.digitalDREAMED DIABETES LTDPHV2022-09-20
00817491023506Eversense DMSSENSEONICS, INCORPORATEDPHV2022-03-10
00817491023513Eversense DMS ProSENSEONICS, INCORPORATEDPHV2022-03-10
00357599826000LibreView GovernmentABBOTT DIABETES CARE INCPHV2021-07-15
00357599823009LibreViewABBOTT DIABETES CARE INCPHV2021-05-21
00763000424121CareLink™ PersonalMEDTRONIC MINIMED, INC.PHV2021-03-07
00763000424138CareLink™MEDTRONIC MINIMED, INC.PHV2021-03-07
00855093008033Glooko Mobile ApplicationGLOOKO, INC.PHV2021-02-16
00855093008040Cornerstones4Care® Powered by Glooko Mobile ApplicationGLOOKO, INC.PHV2021-02-16
00855093008026Glooko Web ApplicationGLOOKO, INC.PHV2021-02-16
00860000249515Onduo VERILY LIFE SCIENCES LLCPHV2020-08-25
00860000249522OnduoVERILY LIFE SCIENCES LLCPHV2020-08-25