Tandem Mobi Cartridge

Basic Information

• Brand Name: Tandem Mobi Cartridge
• Primary DI: 00389152773759
• Version / Model: 1007737
• Company Name: Tandem Diabetes Care, Inc.
• Labeler DUNS: 827900809
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-10-30
• Public Version: 1
• Public Version Date: 2023-11-07
• Public Version Status: New
• Public Device Record Key: 3f8650ba-ec73-417e-9967-f45c89f7c4ae

Device Description

Tandem Mobi Cartridge, 10 Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	880.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35838	Ambulatory insulin infusion pump reservoir	An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00389152000947	GS1
Primary	00389152773759	GS1

Premarket Submissions

Submission Number	Supplement Number
K223213	000