Tandem t:slim AutoSoft XC Kit

GUDID 00389152709574

Tandem t:slim ASFTXC PK10 23"

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir
Primary Device ID00389152709574
NIH Device Record Key28874b9f-b8f1-4e8b-8765-77186b681372
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem t:slim AutoSoft XC Kit
Version Model Number1017095
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
GS100389152709574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2025-06-02
Device Publish Date2025-05-23

On-Brand Devices [Tandem t:slim AutoSoft XC Kit]

00389152709574Tandem t:slim ASFTXC PK10 23"
00389152708379Tandem t:slim ASFTXC PK14 23"

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