MODD1 Patient Welcome Kit

Basic Information

• Brand Name: MODD1 Patient Welcome Kit
• Primary DI: 00850037806126
• Version / Model: MODD1 Insulin Delivery System
• Catalog Number: MTL-277
• 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: 34552371-f037-44b7-8d09-d7d5ade0968a

Device Description

Kit containing one (1) Pump (software version v1.X), Infusion Set Inserter, User Guide, Quick Start Guide, Patient Medical Device Card, and ten (10) of each of the following: Insulin Cartridges, Infusion Sets, Adhesive Pads, Needles, and Syringes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZG	Pump, Infusion, Insulin	General Hospital	880.5725	2
KZH	Introducer, Syringe Needle	General Hospital	880.6920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60415	Insulin infusion cannula introducer	A non-sterile, hand-held, mechanical device intended to aid introduction of a cannula/needle subcutaneously into fatty tissue for use with an insulin infusion pump. It typically consists of a small housing that chambers the cannula and a triggered release mechanism for automated insertion of the cannula/needle into tissues. It is intended for use in the home. This is a reusable device.	No	Active
64889	Ambulatory insulin infusion pump, electronic, non-software-dosing	A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus; it does not include insulin dosage determining software. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850037806126	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163400	000
K240158	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity