MODD1 Patient Welcome Kit MTL-277

GUDID 00850037806126

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.

Modular Medical, Inc.

Ambulatory insulin infusion pump, electronic, non-software-dosing

• Primary Device ID: 00850037806126
• NIH Device Record Key: 34552371-f037-44b7-8d09-d7d5ade0968a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODD1 Patient Welcome Kit
• Version Model Number: MODD1 Insulin Delivery System
• Catalog Number: MTL-277
• Company DUNS: 602638525
• Company Name: Modular Medical, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com
• Phone: 8667101200
• Email: customercare@modular-medical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850037806126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163400

FDA Product Code

• LZG: Pump, Infusion, Insulin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-21
• Device Publish Date: 2025-07-11

Devices Manufactured by Modular Medical, Inc.

• 10850037806000 - MODD1 Adhesive Pad, 10 Pack: 2025-07-21 Box of ten (10) MODD1 Adhesive Pads
• 00850037806010 - MMI App for iOS: 2025-07-21 iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
• 10850037806024 - MODD1 Insulin Cartridge, 10 Pack: 2025-07-21 Box of ten (10) MODD1 Insulin Cartridges
• 10850037806048 - MODD1 Infusion Set, 10 Pack: 2025-07-21 Box of ten (10) MODD1 Infusion Sets
• 00850037806058 - Orbit Inserter: 2025-07-21 Box of one (1) Infusion Set Inserter
• 00850037806065 - MODD1 Supply Kit: 2025-07-21 Kit containing ten (10) of each of the following: Insulin Cartridges, Infusion Sets, Adhesive Pads, Needles, and Syringes.
• 00850037806102 - MODD1 Pump: 2025-07-21 Box of one (1) MODD1 Pump, software version v1.X
• 00850037806119 - MODD1 Starter Kit: 2025-07-21 Kit containing one (1) of each of the following: Pump (software version v1.X), Infusion Set Inserter, User Guide, Quick Start Gu