Tandem Mobi, pump, Control-IQ 7.9

GUDID 00389152480114

Tandem Mobi, pump, Control-IQ 7.x

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Primary Device ID00389152480114
NIH Device Record Keyb31e8b84-310b-4c38-9652-c0c59eb757c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem Mobi, pump, Control-IQ 7.9
Version Model Number1014801
Company DUNS827900809
Company NameTandem Diabetes Care, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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
GS100389152480114 [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 Date2025-05-05
Device Publish Date2025-04-25

Devices Manufactured by Tandem Diabetes Care, Inc.

00389152706474 - Pharmacy Kit, Starter Pack, Tandem T:slim2025-06-02 Tandem t:slim Starter Kit
00389152707679 - Tandem t:slim Autosoft 30 kit2025-06-02 Tandem t:slim ASFT30 PK14 23"
00389152708379 - Tandem t:slim AutoSoft XC Kit2025-06-02 Tandem t:slim ASFTXC PK14 23"
00389152708973 - Tandem t:slim Autosoft 30 kit2025-06-02 Tandem tslim ASFT30 PK10 23"
00389152709574 - Tandem t:slim AutoSoft XC Kit2025-06-02 Tandem t:slim ASFTXC PK10 23"
00389152710174 - Tandem t:slimTruSteel Kit2025-06-02 Tandem t:slim TRUSTL PK10 23"
00389152480114 - Tandem Mobi, pump, Control-IQ 7.92025-05-05Tandem Mobi, pump, Control-IQ 7.x
00389152480114 - Tandem Mobi, pump, Control-IQ 7.92025-05-05 Tandem Mobi, pump, Control-IQ 7.x
00389152523347 - Tandem Mobi Mobile Application2025-04-30 Tandem Mobi Mobile Application

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