t:slim Mobile Application, iOS

GUDID 00389152470740

Tandem t:slim Mobile Application, iOS version 2.9

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Primary Device ID00389152470740
NIH Device Record Key75ea5abc-7279-4342-9b25-80421a581bb1
Commercial Distribution StatusIn Commercial Distribution
Brand Namet:slim Mobile Application, iOS
Version Model Number1014707
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
GS100389152470740 [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.

00389152470641 - Tandem t:slim Mobile Application, Android2025-03-24 Tandem t:slim Mobile Application, Android
00389152470740 - t:slim Mobile Application, iOS2025-03-24Tandem t:slim Mobile Application, iOS version 2.9
00389152470740 - t:slim Mobile Application, iOS2025-03-24 Tandem t:slim Mobile Application, iOS version 2.9
00389152493671 - Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+2025-03-21 Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+
00389152407012 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ 7.x
00389152407111 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Medicare
00389152407210 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Replacement
00389152407319 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Refurbished
00389152559575 - Tandem Mobi Autosoft XC Kit2024-12-31 Autosoft XC, 5"/6mm, 14 pack kit

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