Tandem Mobi Cartridge

GUDID 00389152000947

Tandem Mobi Cartridge, 2 Pack

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00389152000947
• NIH Device Record Key: 96d58e80-9b11-4df5-89b0-2bcc8817ec6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Mobi Cartridge
• Version Model Number: 1007780
• Company DUNS: 827900809
• Company Name: Tandem Diabetes Care, Inc.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00389152000947 [Unit of Use]
GS1	00389152773759 [Primary]
GS1	00389152778051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223213

FDA Product Code

• QFG: Alternate Controller Enabled Insulin Infusion Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-07
• Device Publish Date: 2023-10-30

On-Brand Devices [Tandem Mobi Cartridge]

• 00389152000947: Tandem Mobi Cartridge, 2 Pack
• 00389152375458: Tandem Mobi Cartridge, 2 Pack