Tandem Mobi Autosoft 30 Kit

GUDID 00389152856179

AutoSoft 30, 23"/13mm 14 Pack

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir
Primary Device ID00389152856179
NIH Device Record Key4cfda797-0778-43e2-8453-2f07fcc29258
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem Mobi Autosoft 30 Kit
Version Model Number1018561
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
GS100389152856179 [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 Date2025-12-18
Device Publish Date2025-12-10

On-Brand Devices [Tandem Mobi Autosoft 30 Kit]

00389152312170Autosoft 30, 23"/13mm, 10 pack kit
00389152412177Autosoft 30, 23"/13mm, 10 pack kit
00389152856179AutoSoft 30, 23"/13mm 14 Pack
00389152853772AutoSoft 30, 23"/13mm 10 Pack

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