InPen Smart Insulin Delivery System

Basic Information

• Brand Name: InPen Smart Insulin Delivery System
• Primary DI: 00763000489960
• Version / Model: MMT-8061
• Company Name: MEDTRONIC MINIMED, INC.
• Labeler DUNS: 849626338
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-08
• Public Version: 2
• Public Version Date: 2025-04-01
• Public Version Status: Update
• Public Device Record Key: 4209dbf7-deaa-4436-9fb2-b82be3d13f2b

Device Description

SOFTWARE MMT-8061 INS PEN ANDROID APP

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: Yes
• 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
NDC	Calculator, drug dose	Anesthesiology	868.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45771	Empty self-injector, mechanical	A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000489960	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190487	000
K242775	000