Tandem Mobi Starter Kit

GUDID 00389152311777

with Control-IQ 7.X

Tandem Diabetes Care, Inc.

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

• Primary Device ID: 00389152311777
• NIH Device Record Key: c4f7ff60-3507-41f4-8997-98e6240d94b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Mobi Starter Kit
• Version Model Number: 1013117
• Company DUNS: 827900809
• Company Name: Tandem Diabetes Care, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00389152311777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223213

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: 2024-04-04
• Device Publish Date: 2024-03-27

On-Brand Devices [Tandem Mobi Starter Kit]

• 00389152311777: with Control-IQ 7.X
• 00389152408170: with Control-IQ 7.X