MMI App for iOS

Basic Information

• Brand Name: MMI App for iOS
• Primary DI: 00850037806010
• Version / Model: MODD1 Insulin Delivery System
• Catalog Number: MTL-103
• Company Name: Modular Medical, Inc.
• Labeler DUNS: 602638525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-11
• Public Version: 1
• Public Version Date: 2025-07-21
• Public Version Status: New
• Public Device Record Key: 08550141-8740-4dd4-91b0-e486f3a077ce

Device Description

iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZG	Pump, Infusion, Insulin	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64648	Ambulatory insulin infusion pump software, patient-dosing	A software application intended to allow a patient to remotely control the functions of an electronic ambulatory insulin infusion pump or pump/administration unit (e.g., pharmaceutical delivery, dosage settings), and typically also extract data from the pump. It is intended to be used on a non-medical computerized device (e.g., smartphone) and may transmit data to other platforms for recording/analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850037806010	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240158	000