Tandem t:slim AutoSoft XC Kit

GUDID 00389152708379

Tandem t:slim ASFTXC PK14 23"

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00389152708379
• NIH Device Record Key: 0f28168e-c020-4f6d-a226-c247f46727cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem t:slim AutoSoft XC Kit
• Version Model Number: 1017083
• Company DUNS: 827900809
• Company Name: Tandem Diabetes Care, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389152708379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232380

FDA Product Code

• QFG: Alternate Controller Enabled Insulin Infusion Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23

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

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