Tandem Mobi Autosoft XC Kit

GUDID 00389152411972

Autosoft XC, 5"/6mm, 2 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
Primary Device ID00389152411972
NIH Device Record Key75f26e8c-a8e5-4888-89ea-43d1128cea78
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem Mobi Autosoft XC Kit
Version Model Number1014119
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
GS100389152411972 [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 Date2024-07-01
Device Publish Date2024-06-21

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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