Orbit Inserter MTL-46

GUDID 00850037806058

Box of one (1) Infusion Set Inserter

Modular Medical, Inc.

Insulin infusion cannula introducer

• Primary Device ID: 00850037806058
• NIH Device Record Key: 1441b426-0da1-4355-86e5-cbfac4215ebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbit Inserter
• Version Model Number: MODD1 Insulin Delivery System
• Catalog Number: MTL-46
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850037806058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163400

FDA Product Code

• KZH: Introducer, Syringe Needle

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: 2025-07-21Box of one (1) Infusion Set Inserter
• 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