t:slim X2 Insulin Pump with Basal-IQ

GUDID 00853052007264

t:slim X2 Insulin Pump with Basal-IQ, 6.0

TANDEM DIABETES CARE, INC.

Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system

• Primary Device ID: 00853052007264
• NIH Device Record Key: 4e1e57b8-258d-4ee9-bf14-1ca79ad6ef6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: t:slim X2 Insulin Pump with Basal-IQ
• Version Model Number: 1000886
• 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	00853052007264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180008

FDA Product Code

• OZO: Automated Insulin Dosing , Threshold Suspend

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: 2018-09-03
• Device Publish Date: 2018-08-03

On-Brand Devices [t:slim X2 Insulin Pump with Basal-IQ]

• 00853052007325: t:slim X2 Insulin Pump with Basal-IQ, Refurbished, 6.0
• 00853052007301: t:slim X2 Insulin Pump with Basal-IQ, Reconditioned, 6.0
• 00853052007288: t:slim X2 Insulin Pump with Basal-IQ, Replacement, 6.0
• 00853052007264: t:slim X2 Insulin Pump with Basal-IQ, 6.0
• 00850006613380: t:slim X2 Insulin Pump with Basal-IQ, 6.3.x, Refurbished
• 00850006613373: t:slim X2 Insulin Pump with Basal-IQ, 6.3.x
• 00850006613731: t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Refurbished Replacement
• 00850006613724: t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Replacement
• 00850006613717: t:slim X2 Insulin Pump with Basal-IQ, 6.4.x, Medicare
• 00850006613700: t:slim X2 Insulin Pump with Basal-IQ, 6.4.x
• 00389152000046: t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Refurbished Replacement
• 00389152000039: t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Medicare
• 00389152000022: t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Replacement
• 00389152000015: t:slim X2 Insulin Pump with Basal-IQ, 6.6.x
• 00389152000411: t:slim X2 Insulin Pump with Basal-IQ, 6.6.x