FDA.reportPublic FDA data

t:connect Mobile Application, Mobile Bolus Enabled (iOS)

Primary DI
90850018992452
Brand
t:connect Mobile Application, Mobile Bolus Enabled (iOS)
Company
Tandem Diabetes Care, Inc.
Model
1007111
Device description
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Published
2022-04-15
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
QFGAlternate Controller Enabled Insulin Infusion Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJTContinuous Glucose Monitor Secondary DisplayClinical Chemistry2
QFGAlternate Controller Enabled Insulin Infusion PumpClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90850018992452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9085001899245290850018992452

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump software, data-displayA software application intended to allow a patient or caregiver to remotely extract and view data from an electronic ambulatory insulin infusion pump to support treatment monitoring; it is not intended to control pump settings. It is intended to be installed on an off-the-shelf device (e.g., smartphone).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
827900809
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00389152001005Tandem Mobi Cartridge10152122026-10-20
00389152001012Tandem Mobi Cartridge10152852026-10-20
00389152148250Tandem Mobi Cartridge10114822026-10-20
00389152148359Tandem Mobi Cartridge10114832026-10-20
00389152744957Adhesive Sleeve, 10 Pack, Tandem Mobi10174492026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem Mobi10174542026-10-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00389152001005Tandem Mobi CartridgeTandem Diabetes Care, Inc.QFG2026-10-20
00389152001012Tandem Mobi CartridgeTandem Diabetes Care, Inc.QFG2026-10-20
00389152148250Tandem Mobi CartridgeTandem Diabetes Care, Inc.QFG2026-10-20
00389152148359Tandem Mobi CartridgeTandem Diabetes Care, Inc.QFG2026-10-20
00199150084036MiniMed Flex Starter KitMEDTRONIC, INC.QFG2026-07-19
00199150084043MiniMed Flex Starter KitMEDTRONIC, INC.QFG2026-07-19
00199150084050MiniMed Extended Supply KitMEDTRONIC, INC.QFG2026-07-19
00199150084067MiniMed Extended Supply KitMEDTRONIC, INC.QFG2026-07-19
00199150077380MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-25
00199150021031MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-24
00763000848149MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00763000848156MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00850050080367iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00850050080374iLet Starter KitBeta Bionics, Inc.QFG2026-03-11
00850050080381iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00389152547244Tandem Mobi Mobile Application, AndroidTandem Diabetes Care, Inc.QFG2025-12-16
00389152858173Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152858777Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152859477Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152852379Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152852973Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152853772Tandem Mobi Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152854373Tandem Mobi TruSteel KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152854977Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152855578Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152856179Tandem Mobi Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152856971Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152857572Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
B553202407OTC0Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PJT2025-12-09
10385083000411Omnipod 5 PodInsulet CorporationQFG2025-12-04