FDA.reportPublic FDA data

t:slim X2 Cartridge, t:lock, 2 Pack

Primary DI
00853052007233
Brand
t:slim X2 Cartridge, t:lock, 2 Pack
Company
Tandem Diabetes Care, Inc.
Model
1000728
Device description
t:slim G4 / X2 Cartridge, t:lock, 2 Pack
Published
2017-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose SensorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140015000
P140015001
P140015002
P140015003
P140015004
P140015005
P140015013
P140015014
P140015017
P140015019

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140015000T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015001T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015002T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015003T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015004T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015005T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015013T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015014T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015017T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC
P140015019T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMTandem Diabetes Care, Inc.2015-09-08OYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853052007233PrimaryGS10
00853052007547Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853052007233008530520072338530520072330853052007233
00853052007547008530520075478530520075470853052007547

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump reservoirAn insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
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
2
Lot or batch
true
Expiration 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
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
00853052007981t:slim X2 5.x Insulin PumpTandem Diabetes Care, Inc.OYC2021-05-18
00763000423124Paradigm® REAL-TimeMEDTRONIC MINIMED, INC.OYC2020-11-15
00763000423131Paradigm® REAL-Time Revel™MEDTRONIC MINIMED, INC.OYC2020-11-15
00853052007967t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2018-10-15
00763000161088PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.OYC2018-09-30
00763000161132Paradigm® REAL-Time Revel™MEDTRONIC MINIMED, INC.OYC2018-09-28
00763000164300MiniLink® REAL-TimeMEDTRONIC MINIMED, INC.OYC2018-07-07
10840406103106Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103601Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103137Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103168Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103199Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103229Animas VibeANIMAS CORPORATIONOYC2018-01-15
00643169933125PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.OYC2017-11-30
00643169933170Paradigm® REAL-Time Revel™MEDTRONIC MINIMED, INC.OYC2017-11-30
20643169786725Enlite ®MEDTRONIC MINIMED, INC.OYC2017-11-25
10840406103823Animas VibeANIMAS CORPORATIONOYC2017-09-21
10840406105261Animas VibeANIMAS CORPORATIONOYC2017-09-21
00853052007257t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2017-08-28
00853052007271t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2017-08-28
00853052007295t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2017-08-28
00853052007318t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2017-08-28
00853052007226t:slim X2 Cartridge, t:lock, 10 PackTandem Diabetes Care, Inc.OYC2017-08-25
20613994598404SOF-SENSOR ®MEDTRONIC MINIMED, INC.OYC2016-10-10
00643169283183Medtronic Guardian™ LinkMEDTRONIC MINIMED, INC.OYC2016-09-23
00643169462724Enlite™ SerterMEDTRONIC MINIMED, INC.OYC2016-08-14
00613994933072Enlite™ SerterMEDTRONIC MINIMED, INC.OYC2016-08-14
00852162004613t:slim G4 Insulin Pump, Reconditioned ReplacementTandem Diabetes Care, Inc.OYC2016-08-11
00852162004750t:slim G4 Insulin Pump, ReconditionedTandem Diabetes Care, Inc.OYC2016-08-11
00852162004439t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, ReplacementTandem Diabetes Care, Inc.OYC2016-03-25