Tandem t:slim Autosoft 30 kit

GUDID 00389152708973

Tandem tslim ASFT30 PK10 23"

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00389152708973
• NIH Device Record Key: 31a9721b-6793-4f88-b62d-874fbef8c7c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem t:slim Autosoft 30 kit
• Version Model Number: 1017089
• 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	00389152708973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232380

FDA Product Code

• QJI: Interoperable Automated Glycemic Controller

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 30 kit]

• 00389152708973: Tandem tslim ASFT30 PK10 23"
• 00389152707679: Tandem t:slim ASFT30 PK14 23"