Pharmacy Kit, Starter Pack, Tandem T:slim

GUDID 00389152706474

Tandem t:slim Starter Kit

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Primary Device ID00389152706474
NIH Device Record Keyb51b1aed-7381-47c3-856e-c9b5207c8e8c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePharmacy Kit, Starter Pack, Tandem T:slim
Version Model Number1017064
Company DUNS827900809
Company NameTandem Diabetes Care, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100389152706474 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFGAlternate Controller Enabled Insulin Infusion Pump

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-02
Device Publish Date2025-05-23

Devices Manufactured by Tandem Diabetes Care, Inc.

00389152858173 - Tandem t:slim Autosoft 30 Kit2025-12-22 AutoSoft 30, 23"13 mm 10 Pack
00389152858777 - Tandem t:slim Autosoft XC Kit2025-12-22 AutoSoft XC, 23"/6 mm 10 Pack
00389152859477 - Tandem t:slimTruSteel Kit2025-12-22 TruSteel, 23"/6 mm 10 Pack
00389152852379 - Tandem Mobi Autosoft XC Kit2025-12-18 AutoSoft XC, 5"/6mm 10 Pack
00389152852973 - Tandem Mobi Autosoft XC Kit2025-12-18 AutoSoft XC, 23"/6mm 10 Pack
00389152853772 - Tandem Mobi Autosoft 30 Kit2025-12-18 AutoSoft 30, 23"/13mm 10 Pack
00389152854373 - Tandem Mobi TruSteel Kit2025-12-18 TruSteel, 23"/6mm 10 Pack
00389152854977 - Tandem Mobi Autosoft XC Kit2025-12-18 AutoSoft XC, 5"/6mm 14 Pack

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