Tandem Mobi Mobile Application

GUDID 00389152523347

Tandem Mobi Mobile Application

Tandem Diabetes Care, Inc.

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

• Primary Device ID: 00389152523347
• NIH Device Record Key: 88e47644-29a9-4c7b-9b7e-aed935632f32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Mobi Mobile Application
• Version Model Number: 1015233
• 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	00389152523347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241078

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: 2025-04-30
• Device Publish Date: 2025-04-22

Devices Manufactured by Tandem Diabetes Care, Inc.

• 00389152480114 - Tandem Mobi, pump, Control-IQ 7.9: 2025-05-05 Tandem Mobi, pump, Control-IQ 7.x
• 00389152523347 - Tandem Mobi Mobile Application: 2025-04-30Tandem Mobi Mobile Application
• 00389152523347 - Tandem Mobi Mobile Application: 2025-04-30 Tandem Mobi Mobile Application
• 00389152470641 - Tandem t:slim Mobile Application, Android: 2025-03-24 Tandem t:slim Mobile Application, Android
• 00389152470740 - t:slim Mobile Application, iOS: 2025-03-24 Tandem t:slim Mobile Application, iOS version 2.9
• 00389152493671 - Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+: 2025-03-21 Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+
• 00389152407012 - t:slim X2 Insulin Pump with Control-IQ+ Technology: 2025-01-30 Control-IQ 7.x
• 00389152407111 - t:slim X2 Insulin Pump with Control-IQ+ Technology: 2025-01-30 Control-IQ+ 7.x, Medicare
• 00389152407210 - t:slim X2 Insulin Pump with Control-IQ+ Technology: 2025-01-30 Control-IQ+ 7.x, Replacement