Tandem t:slim Mobile Application, Android

GUDID 00389152470641

Tandem t:slim Mobile Application, Android

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

• Primary Device ID: 00389152470641
• NIH Device Record Key: 4fe0c269-3ccd-4132-b122-07e3461aeac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem t:slim Mobile Application, Android
• Version Model Number: 1014706
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00389152470641 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-24
• Device Publish Date: 2025-03-14

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: 2025-06-02 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