t:slim X2 Insulin Pump with Control-IQ Technology

GUDID 00389152286815

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

• Primary Device ID: 00389152286815
• NIH Device Record Key: 59547393-6f21-43f5-81d9-48ef955df727
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: t:slim X2 Insulin Pump with Control-IQ Technology
• Version Model Number: 1012868
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389152286815 [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: 2023-10-30
• Device Publish Date: 2023-10-20

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

• 00389152287010: 1012870
• 00389152286914: 1012869
• 00389152286815: 1012868
• 00389152286716: 1012867
• 00389152319810: Control-IQ 7.8
• 00389152319711: Control-IQ 7.8
• 00389152319612: Control-IQ 7.8
• 00389152319513: Control-IQ 7.8