FDA.reportPublic FDA data

Tandem Mobi Mobile Application, iOS

Primary DI
00389152690940
Brand
Tandem Mobi Mobile Application, iOS
Company
Tandem Diabetes Care, Inc.
Model
1016909
Device description
Tandem Mobi Mobile Application
Published
2025-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QFGAlternate Controller Enabled Insulin Infusion Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFGAlternate Controller Enabled Insulin Infusion PumpClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241078000Tandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc.2024-07-26QFG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00389152690940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00389152690940003891526909403891526909400389152690940

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithmA portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.

Regulatory Flags#

DUNS number
827900809
Device count
1
Serial number
true
Manufacturing date on label
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
00389152707679Tandem t:slim Autosoft 30 kit10170762025-05-23
00389152708379Tandem t:slim AutoSoft XC Kit10170832025-05-23
00389152708973Tandem t:slim Autosoft 30 kit10170892025-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10385083000411Omnipod 5 PodInsulet CorporationQFG2025-12-04
20385083000425Omnipod 5 PodInsulet CorporationQFG2025-12-04
00199150047055MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.QFG2025-11-08
00389152706474Pharmacy Kit, Starter Pack, Tandem t:slim X2, Control IQ+Tandem Diabetes Care, Inc.QFG2025-05-23
00389152707679Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QFG2025-05-23
00389152708379Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152708973Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QFG2025-05-23
00389152709574Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152710174Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152480114Tandem Mobi, pump, Control-IQ 7.9Tandem Diabetes Care, Inc.QFG2025-04-25