FDA.reportPublic FDA data

LibreLinkUp

Primary DI
00357599824006
Brand
LibreLinkUp
Company
ABBOTT DIABETES CARE INC
Model
72154-01
Catalog number
72154-01
Device description
LibreLinkUp
Published
2021-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJTContinuous glucose monitor secondary display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJTContinuous Glucose Monitor Secondary DisplayClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00357599824006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00357599824006003575998240063575998240060357599824006

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.

Sterilization Methods#

Method table
Method

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
B553202407OTC0Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PJT2025-12-09
00386270004475Dexcom Follow 5 Android MobileDexcom, Inc.PJT2025-10-10
00386270004482Dexcom Follow 5 iOS MobileDexcom, Inc.PJT2025-10-10
00386270004802Dexcom Follow 5 iOS Watch Mobile AppDexcom, Inc.PJT2025-10-10
00199150034130MiniMed Mobile AppMEDTRONIC MINIMED, INC.PJT2025-09-26
B553202258OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PJT2025-05-29
B553202058OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PJT2024-12-27
00763000968175MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2024-09-30
00763000943264MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2024-07-28
00763000910150MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2024-03-08
00763000867638MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2023-11-27
00763000827793MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2023-05-20
00386270001917Dexcom Follow App for AndroidDexcom, Inc.PJT2023-05-16
00386270001931Dexcom Follow App for iOSDexcom, Inc.PJT2023-05-16
90850018992445t:connect Mobile Application, Mobile Bolus Enabled (Android)Tandem Diabetes Care, Inc.PJT2022-04-15
90850018992452t:connect Mobile Application, Mobile Bolus Enabled (iOS)Tandem Diabetes Care, Inc.PJT2022-04-15
00817491023490Eversense NOW Mobile App AndroidSENSEONICS, INCORPORATEDPJT2022-01-21
00850006613267t:connect Mobile Application (Android)Tandem Diabetes Care, Inc.PJT2019-12-18
00850006613274t:connect Mobile Application (iOS)Tandem Diabetes Care, Inc.PJT2019-12-18
00817491021267Eversense® NOW Mobile App iOSSENSEONICS, INCORPORATEDPJT2018-07-18