Tandem Mobi Starter Kit

GUDID 00389152311777

with Control-IQ 7.X

Tandem Diabetes Care, Inc.

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• 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

Devices Manufactured by Tandem Diabetes Care, Inc.

• 00389152311777 - Tandem Mobi Starter Kit: 2024-04-04with Control-IQ 7.X
• 00389152311777 - Tandem Mobi Starter Kit: 2024-04-04 with Control-IQ 7.X
• 00389152311876 - Tandem Mobi Autosoft XC Kit: 2024-03-29 Autosoft XC, 5"/6mm, 2 pack kit
• 00389152311975 - Tandem Mobi Autosoft XC Kit: 2024-03-29 Autosoft XC, 5"/6mm, 2 pack kit
• 00389152312071 - Tandem Mobi Autosoft XC Kit: 2024-03-29 Autosoft XC 23"/6mm 10 pack
• 00389152312170 - Tandem Mobi Autosoft 30 Kit: 2024-03-29 Autosoft 30, 23"/13mm, 10 pack kit
• 00389152312279 - Tandem Mobi TruSteel Kit: 2024-03-29 TruSteel, 23"/6mm, 10 pack kit
• 00389152319513 - t:slim X2 Insulin Pump with Control-IQ Technology: 2023-12-14 Control-IQ 7.8
• 00389152319612 - t:slim X2 Insulin Pump with Control-IQ Technology: 2023-12-14 Control-IQ 7.8