InPen Smart Insulin Delivery System

Primary DI

62088-0000-34

Brand

InPen Smart Insulin Delivery System

Company

COMPANION MEDICAL, INC.

Model

Novo - Blue

Catalog number

InPen-100NN-BL / MMT-105NNBL

Device description

The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Novo Nordisk Novolog® U-100 3.0 mL cartridges of insulin and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.

Published

2017-05-01

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

false