Tandem Mobi Cartridge

GUDID 00389152375458

Tandem Mobi Cartridge, 2 Pack

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00389152375458
• NIH Device Record Key: 4afdfb93-9f44-4521-bd40-e9956858e3ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Mobi Cartridge
• Version Model Number: 1013754
• Company DUNS: 827900809
• Company Name: Tandem Diabetes Care, Inc.
• Device Count: 1
• 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: true
• 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	00389152375458 [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: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [Tandem Mobi Cartridge]

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