MODD1 Insulin Cartridge, 10 Pack

Basic Information

• Brand Name: MODD1 Insulin Cartridge, 10 Pack
• Primary DI: 00850037806027
• Version / Model: MODD1 Insulin Delivery System
• Catalog Number: MTL-34
• Company Name: Modular Medical, Inc.
• Labeler DUNS: 602638525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• 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: ea8e74c2-0574-4e55-b25b-92186bfaa201

Device Description

Box of ten (10) MODD1 Insulin Cartridges

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
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	10850037806024	GS1
Primary	00850037806027	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K240158	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 122 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity