Tandem Mobi TruSteel Kit

GUDID 00389152312279

TruSteel, 23"/6mm, 10 pack kit

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00389152312279
• NIH Device Record Key: 130e9c3d-94db-44ea-a1f4-194031739959
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Mobi TruSteel Kit
• Version Model Number: 1013122
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	00389152312279 [Primary]

FDA Product Code

• QFG: Alternate Controller Enabled Insulin Infusion Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-29
• Device Publish Date: 2024-03-21

Devices Manufactured by Tandem Diabetes Care, Inc.

• 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: 2024-03-29TruSteel, 23"/6mm, 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