Tandem Mobi Autosoft XC Kit

GUDID 00389152311975

Autosoft XC, 5"/6mm, 2 pack kit

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir
Primary Device ID00389152311975
NIH Device Record Key7f0ddd08-a68a-4d88-a89f-55b4e2517fae
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem Mobi Autosoft XC Kit
Version Model Number1013119
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
GS100389152311975 [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

On-Brand Devices [Tandem Mobi Autosoft XC Kit]

00389152312071Autosoft XC 23"/6mm 10 pack
00389152311975Autosoft XC, 5"/6mm, 2 pack kit
00389152311876Autosoft XC, 5"/6mm, 2 pack kit
00389152412078Autosoft XC 23"/6mm 10 pack
00389152411972Autosoft XC, 5"/6mm, 2 pack kit
00389152411873Autosoft XC, 5"/6mm, 10 pack kit

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