t:slim X2 Insulin Pump with Basal-IQ 1010006

GUDID 00389152000039

t:slim X2 Insulin Pump with Basal-IQ, 6.6.x, Medicare

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 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: 00389152000039
• NIH Device Record Key: c1ec72ee-9f40-456c-b9db-8bbe0a4c4c0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: t:slim X2 Insulin Pump with Basal-IQ
• Version Model Number: 1009638
• Catalog Number: 1010006
• 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
• 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
• 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	00389152000039 [Primary]

FDA Product Code

• QFG: Alternate Controller Enabled Insulin Infusion Pump

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: 2022-04-25
• Device Publish Date: 2022-04-15

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