t:flex Cartridge, t:lock, 10 Pack

GUDID 00853052007493

t:flex Insulin Pump Cartridges, t:lock, 10 pack

TANDEM DIABETES CARE, INC.

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00853052007493
• NIH Device Record Key: b17c2df0-cfd4-480e-b1a0-93705693d657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: t:flex Cartridge, t:lock, 10 Pack
• Version Model Number: 1001390
• Company DUNS: 827900809
• Company Name: TANDEM DIABETES CARE, INC.
• Device Count: 10
• 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: 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

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

Device Dimensions

• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter
• Total Volume: 4.8 Milliliter

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853052007493 [Primary]
GS1	00853052007530 [Unit of Use]

FDA Product Code

• LZG: Pump, Infusion, Insulin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-25

Devices Manufactured by TANDEM DIABETES CARE, INC.

• 00389152547244 - Tandem Mobi Mobile Application, Android: 2025-12-24 Tandem Mobi Mobile Application, Android
• 00389152858173 - Tandem t:slim Autosoft 30 Kit: 2025-12-22 AutoSoft 30, 23"13 mm 10 Pack
• 00389152858777 - Tandem t:slim Autosoft XC Kit: 2025-12-22 AutoSoft XC, 23"/6 mm 10 Pack
• 00389152859477 - Tandem t:slimTruSteel Kit: 2025-12-22 TruSteel, 23"/6 mm 10 Pack
• 00389152852379 - Tandem Mobi Autosoft XC Kit: 2025-12-18 AutoSoft XC, 5"/6mm 10 Pack
• 00389152852973 - Tandem Mobi Autosoft XC Kit: 2025-12-18 AutoSoft XC, 23"/6mm 10 Pack
• 00389152853772 - Tandem Mobi Autosoft 30 Kit: 2025-12-18 AutoSoft 30, 23"/13mm 10 Pack
• 00389152854373 - Tandem Mobi TruSteel Kit: 2025-12-18 TruSteel, 23"/6mm 10 Pack