FDA.reportPublic FDA data

t:slim X2 Insulin Pump with Basal-IQ

Primary DI
00850006613373
Brand
t:slim X2 Insulin Pump with Basal-IQ
Company
Tandem Diabetes Care, Inc.
Model
1005698
Device description
t:slim X2 Insulin Pump with Basal-IQ, 6.3.x
Published
2020-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZOAutomated Insulin Dosing , Threshold Suspend

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZOAutomated Insulin Dosing , Threshold SuspendUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180008000
P180008001
P180008002
P180008003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180008000t:slim X2 Insulin Pump with Basal-IQ TechnologyTandem Diabetes Care, Inc.2018-06-21OZO
P180008001t:slim X2 Insulin Pump with Basal-IQ TechnologyTandem Diabetes Care, Inc.2018-06-21OZO
P180008002t:slim X2 Insulin Pump with Basal-IQ TechnologyTandem Diabetes Care, Inc.2018-06-21OZO
P180008003t:slim X2 Insulin Pump with Basal-IQ TechnologyTandem Diabetes Care, Inc.2018-06-21OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006613373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006613373008500066133738500066133730850006613373

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
00643169455535ENLiTE™MEDTRONIC MINIMED, INC.OZO2023-07-20
00763000391041Guardian™ Link (3)MEDTRONIC XOMED, INC.OZO2020-10-26
00763000391065Guardian™ Link (3)MEDTRONIC MINIMED, INC.OZO2020-10-26
00763000389024Guardian ™ Link (3)MEDTRONIC XOMED, INC.OZO2020-09-06
00763000400620Guardian™ Link (3)MEDTRONIC MINIMED, INC.OZO2020-09-06
00763000337049Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-11
20763000337005Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-10
00763000337001Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-10
00763000395858MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2020-07-06
00763000367091MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2020-05-18
00763000341923One-press SerterMEDTRONIC MINIMED, INC.OZO2020-05-16
00763000367053MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2020-05-16
00763000367060MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2020-05-16
00850006613380t:slim X2 Insulin Pump with Basal-IQTandem Diabetes Care, Inc.OZO2020-02-04
00763000317591MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317607MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317614MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317621MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000316631MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316648MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316655MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316662MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316679MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316686MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
10301937550154CONTOUR®NEXTASCENSIA DIABETES CARE US INC.OZO2019-08-30
00763000283445MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2019-08-29
00763000256807MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000256814MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000256838MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000190439MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-03-11