Tandem Mobi Mobile Application, Android

GUDID 00389152547244

Tandem Mobi Mobile Application, Android

Tandem Diabetes Care, Inc.

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

• Primary Device ID: 00389152547244
• NIH Device Record Key: 6b250b62-7844-48e4-aa5d-a735edae2879
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Mobi Mobile Application, Android
• Version Model Number: 1015472
• 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: false
• 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	00389152547244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253074

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: 2025-12-24
• Device Publish Date: 2025-12-16

Devices Manufactured by Tandem Diabetes Care, Inc.

• 00389152547244 - Tandem Mobi Mobile Application, Android: 2025-12-24Tandem Mobi Mobile Application, Android
• 00389152547244 - Tandem Mobi Mobile Application, Android: 2025-12-24 Tandem Mobi Mobile Application, Android
• 00389152858173 - Tandem t:slim Autosoft 30 Kit: 2025-12-22 AutoSoft 30, 23"13 mm 10 Pack
• 00389152858777 - Tandem t:slim Autosoft XC Kit: 2025-12-22 AutoSoft XC, 23"/6 mm 10 Pack
• 00389152859477 - Tandem t:slimTruSteel Kit: 2025-12-22 TruSteel, 23"/6 mm 10 Pack
• 00389152852379 - Tandem Mobi Autosoft XC Kit: 2025-12-18 AutoSoft XC, 5"/6mm 10 Pack
• 00389152852973 - Tandem Mobi Autosoft XC Kit: 2025-12-18 AutoSoft XC, 23"/6mm 10 Pack
• 00389152853772 - Tandem Mobi Autosoft 30 Kit: 2025-12-18 AutoSoft 30, 23"/13mm 10 Pack
• 00389152854373 - Tandem Mobi TruSteel Kit: 2025-12-18 TruSteel, 23"/6mm 10 Pack