Tandem t:slimTruSteel Kit

GUDID 00389152710174

Tandem t:slim TRUSTL PK10 23"

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00389152710174
• NIH Device Record Key: 51a60470-9a85-425c-b5cc-1abf2e76ee08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem t:slimTruSteel Kit
• Version Model Number: 1017101
• 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	00389152710174 [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

Devices Manufactured by Tandem Diabetes Care, Inc.

• 00389152706474 - Pharmacy Kit, Starter Pack, Tandem T:slim: 2025-06-02 Tandem t:slim Starter Kit
• 00389152707679 - Tandem t:slim Autosoft 30 kit: 2025-06-02 Tandem t:slim ASFT30 PK14 23"
• 00389152708379 - Tandem t:slim AutoSoft XC Kit: 2025-06-02 Tandem t:slim ASFTXC PK14 23"
• 00389152708973 - Tandem t:slim Autosoft 30 kit: 2025-06-02 Tandem tslim ASFT30 PK10 23"
• 00389152709574 - Tandem t:slim AutoSoft XC Kit: 2025-06-02 Tandem t:slim ASFTXC PK10 23"
• 00389152710174 - Tandem t:slimTruSteel Kit: 2025-06-02Tandem t:slim TRUSTL PK10 23"
• 00389152710174 - Tandem t:slimTruSteel Kit: 2025-06-02 Tandem t:slim TRUSTL PK10 23"
• 00389152480114 - Tandem Mobi, pump, Control-IQ 7.9: 2025-05-05 Tandem Mobi, pump, Control-IQ 7.x
• 00389152523347 - Tandem Mobi Mobile Application: 2025-04-30 Tandem Mobi Mobile Application