FDA.reportPublic FDA data

Tandem t:slim Autosoft 30 Kit

Primary DI
00389152858173
Brand
Tandem t:slim Autosoft 30 Kit
Company
Tandem Diabetes Care, Inc.
Model
1018581
Device description
"AutoSoft 30, 23""13 mm 10 Pack"
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular
QFGAlternate Controller Enabled Insulin Infusion Pump
QJIInteroperable Automated Glycemic Controller

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
QFGAlternate Controller Enabled Insulin Infusion PumpClinical Chemistry2
QJIInteroperable Automated Glycemic ControllerClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232380000
K232382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232380000t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.2023-11-03QFG
K232382000Control-IQ TechnologyTandem Diabetes Care, Inc.2023-11-03QJI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00389152858173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00389152858173003891528581733891528581730389152858173

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
827900809
Device count
1
Kit
true
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
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
00389152708973Tandem t:slim Autosoft 30 kit10170892025-05-23

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