Tandem Mobi Adhesive Sleeve

GUDID 00389152000961

Tandem Diabetes Care, Inc.

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

• Primary Device ID: 00389152000961
• NIH Device Record Key: cf950fc4-c497-4615-8600-a751316afac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Mobi Adhesive Sleeve
• Version Model Number: 1010123
• Company DUNS: 827900809
• Company Name: Tandem Diabetes Care, Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389152000961 [Unit of Use]
GS1	00389152076157 [Primary]
GS1	00389152076256 [Primary]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

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: 2023-12-13
• Device Publish Date: 2023-12-05

Devices Manufactured by Tandem Diabetes Care, Inc.

• 00389152408170 - Tandem Mobi Starter Kit: 2024-07-01 with Control-IQ 7.X
• 00389152411873 - Tandem Mobi Autosoft XC Kit: 2024-07-01 Autosoft XC, 5"/6mm, 10 pack kit
• 00389152411972 - Tandem Mobi Autosoft XC Kit: 2024-07-01 Autosoft XC, 5"/6mm, 2 pack kit
• 00389152412078 - Tandem Mobi Autosoft XC Kit: 2024-07-01 Autosoft XC 23"/6mm 10 pack
• 00389152412177 - Tandem Mobi Autosoft 30 Kit: 2024-07-01 Autosoft 30, 23"/13mm, 10 pack kit
• 00389152412276 - Tandem Mobi TruSteel Kit: 2024-07-01 TruSteel, 23"/6mm, 10 pack kit
• 00389152365510 - Tandem Mobi: 2024-05-31 Tandem Mobi Pump with Control-IQ
• 00389152365619 - Tandem Mobi: 2024-05-31 Tandem Mobi Pump with Control-IQ, Replacement