t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM

GUDID 00852162004408

The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions.

TANDEM DIABETES CARE, INC.

Ambulatory insulin infusion pump/blood glucose analyser system

• Primary Device ID: 00852162004408
• NIH Device Record Key: 88428bbf-16ac-418d-b123-45d0e686a814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
• Version Model Number: 006194
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com
• Phone: 877-801-6901
• Email: TandemCares@tandemdiabetes.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852162004408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140015

FDA Product Code

• OYC: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-15

Devices Manufactured by TANDEM DIABETES CARE, INC.

• 00389152386058 - t:slim X2 Cartridge, t:lock, 10 Pack: 2024-09-09 Cartridge, t:slim, t:lock, 10 Pack
• 00389152375458 - Tandem Mobi Cartridge: 2024-07-30 Tandem Mobi Cartridge, 2 Pack
• 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