Tandem Mobi Autosoft 30 Kit

GUDID 00389152312170

Autosoft 30, 23"/13mm, 10 pack kit

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir
Primary Device ID00389152312170
NIH Device Record Keyf69f7d55-4da0-4388-9162-18976e8cf30a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem Mobi Autosoft 30 Kit
Version Model Number1013121
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS100389152312170 [Primary]

FDA Product Code

QFGAlternate Controller Enabled Insulin Infusion Pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-29
Device Publish Date2024-03-21

Devices Manufactured by Tandem Diabetes Care, Inc.

00389152311777 - Tandem Mobi Starter Kit2024-04-04 with Control-IQ 7.X
00389152311876 - Tandem Mobi Autosoft XC Kit2024-03-29 Autosoft XC, 5"/6mm, 2 pack kit
00389152311975 - Tandem Mobi Autosoft XC Kit2024-03-29 Autosoft XC, 5"/6mm, 2 pack kit
00389152312071 - Tandem Mobi Autosoft XC Kit2024-03-29 Autosoft XC 23"/6mm 10 pack
00389152312170 - Tandem Mobi Autosoft 30 Kit2024-03-29Autosoft 30, 23"/13mm, 10 pack kit
00389152312170 - Tandem Mobi Autosoft 30 Kit2024-03-29 Autosoft 30, 23"/13mm, 10 pack kit
00389152312279 - Tandem Mobi TruSteel Kit2024-03-29 TruSteel, 23"/6mm, 10 pack kit
00389152319513 - t:slim X2 Insulin Pump with Control-IQ Technology2023-12-14 Control-IQ 7.8
00389152319612 - t:slim X2 Insulin Pump with Control-IQ Technology2023-12-14 Control-IQ 7.8

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