t:slim Cartridge, t:lock, 10 Pack

GUDID 00853052007516

t:slim Cartridge, t:lock, 10 Pack

TANDEM DIABETES CARE, INC.

Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00853052007516
• NIH Device Record Key: ebd963f2-48b6-4244-8afd-4f040eb3d9dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: t:slim Cartridge, t:lock, 10 Pack
• Version Model Number: 1000991
• 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: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 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	00853052007516 [Primary]
GS1	00853052007523 [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

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