FDA.reportPublic FDA data

t:slim X2 Insulin Pump with Control-IQ

Primary DI
00850006613779
Brand
t:slim X2 Insulin Pump with Control-IQ
Company
Tandem Diabetes Care, Inc.
Model
1006404
Device description
t:slim X2 Insulin Pump with Control-IQ, 7.4.x, Medicare
Published
2021-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDCCalculator, Drug Dose
QFGAlternate Controller Enabled Insulin Infusion Pump
QJIInteroperable Automated Glycemic Controller

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDCCalculator, Drug DoseAnesthesiology2
QFGAlternate Controller Enabled Insulin Infusion PumpClinical Chemistry2
QJIInteroperable Automated Glycemic ControllerClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006613779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006613779008500066137798500066137790850006613779

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump/blood glucose analyser systemAn assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
827900809
Device count
1
Serial number
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
00199150002375MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00199150002382MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
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
00860008440129iSage Rx Amalgam RX, Inc.NDC2026-04-22
B553202153OTC0Conifer Connect DiabetesWELLDOC, INC.NDC2026-03-30
00850050080367iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00850050080374iLet Starter KitBeta Bionics, Inc.QJI2026-03-11
00850050080374iLet Starter KitBeta Bionics, Inc.QFG2026-03-11
00850050080381iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00860015223906UpDocUpDoc Inc.NDC2026-01-13
00389152547244Tandem Mobi Mobile Application, AndroidTandem Diabetes Care, Inc.QFG2025-12-16
00389152858173Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152858173Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QJI2025-12-12
00389152858777Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152858777Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QJI2025-12-12
00389152859477Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QJI2025-12-12
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
00389152856971Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QJI2025-12-10
00389152857572Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10