Tandem t:slim Mobile Application, Android

GUDID 00389152470641

Tandem t:slim Mobile Application, Android

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Primary Device ID00389152470641
NIH Device Record Key4fe0c269-3ccd-4132-b122-07e3461aeac6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem t:slim Mobile Application, Android
Version Model Number1014706
Company DUNS827900809
Company NameTandem Diabetes Care, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100389152470641 [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 Date2025-03-24
Device Publish Date2025-03-14

Devices Manufactured by Tandem Diabetes Care, Inc.

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
00389152855578 - Tandem Mobi Autosoft XC Kit2025-12-18 AutoSoft XC, 23"/6mm 14 Pack
00389152856179 - Tandem Mobi Autosoft 30 Kit2025-12-18 AutoSoft 30, 23"/13mm 14 Pack
00389152856971 - Tandem t:slim Autosoft 30 Kit2025-12-18 AutoSoft 30, 23"/13 mm 14 Pack

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