FDA.reportPublic FDA data

t:connect Mobile Application (iOS)

Primary DI
00850006613274
Brand
t:connect Mobile Application (iOS)
Company
Tandem Diabetes Care, Inc.
Model
1004128
Device description
t:connect Mobile Application (iOS)
Published
2019-12-18
Public version status
Update
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
00850006613274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006613274008500066132748500066132740850006613274

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump remote control/blood glucose analyserA portable electronic device designed to: 1) remotely control an electronic ambulatory insulin infusion pump; and 2) measure blood glucose levels to aid a diabetes mellitus patient in self-management of insulin therapy. It consists of a wireless unit that interfaces with the pump (not included) to control and program pump functions and receive pump status information, and which incorporates a blood glucose meter and built-in test strip port for the in vitro quantitative measurement of glucose in harvested capillary blood.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-801-6901TandemCares@tandemdiabetes.com

Regulatory Flags#

DUNS number
827900809
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00389152319513t:slim X2 Insulin Pump with Control-IQ Technology10131952023-12-06
00389152319711t:slim X2 Insulin Pump with Control-IQ Technology10131972023-12-06
00389152319810t:slim X2 Insulin Pump with Control-IQ Technology10131982023-12-06
00389152706474Pharmacy Kit, Starter Pack, Tandem t:slim X2, Control IQ+10170642025-05-23
00389152547244Tandem Mobi Mobile Application, Android10154722025-12-16
00389152858173Tandem t:slim Autosoft 30 Kit10185812025-12-12
00389152858777Tandem t:slim Autosoft XC Kit10185872025-12-12
00389152859477Tandem t:slimTruSteel Kit10185942025-12-12
00389152852379Tandem Mobi Autosoft XC Kit10185232025-12-10
00389152852973Tandem Mobi Autosoft XC Kit10185292025-12-10
00389152853772Tandem Mobi Autosoft 30 Kit10185372025-12-10
00389152854373Tandem Mobi TruSteel Kit10185432025-12-10
00389152854977Tandem Mobi Autosoft XC Kit10185492025-12-10
00389152855578Tandem Mobi Autosoft XC Kit10185552025-12-10
00389152856179Tandem Mobi Autosoft 30 Kit10185612025-12-10
00389152856971Tandem t:slim Autosoft 30 Kit10185692025-12-10
00389152857572Tandem t:slim Autosoft XC Kit10185752025-12-10
00389152690940Tandem Mobi Mobile Application, iOS10169092025-10-06
00389152707679Tandem t:slim Autosoft 30 kit10170762025-05-23
00389152708379Tandem t:slim AutoSoft XC Kit10170832025-05-23

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
00357599824006LibreLinkUpABBOTT DIABETES CARE INCPJT2021-05-25
00850006613267t:connect Mobile Application (Android)Tandem Diabetes Care, Inc.PJT2019-12-18
00817491021267Eversense® NOW Mobile App iOSSENSEONICS, INCORPORATEDPJT2018-07-18