| Primary Device ID | 62088-0000-35 |
| NIH Device Record Key | bdea1908-12e8-4835-91aa-8274f4930319 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InPen Smart Insulin System |
| Version Model Number | Novo - Grey |
| Catalog Number | InPen-100NN-GY / MMT-105NNGY |
| Company DUNS | 057594435 |
| Company Name | COMPANION MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| 00763000645281 - inpen™ | 2022-08-16 |
| 00763000645298 - inpen™ | 2022-08-16 |
| 62088-0000-31 - InPen Smart Insulin Delivery System | 2021-02-01 The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injec |
| 62088-0000-32 - InPen Smart Insulin Delivery System | 2021-02-01 The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injec |
| 62088-0000-33 - InPen Smart Insulin Delivery System | 2021-02-01 The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injec |
| 62088-0000-34 - InPen Smart Insulin Delivery System | 2021-02-01 The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injec |
| 62088-0000-35 - InPen Smart Insulin System | 2021-02-01The 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. |
| 62088-0000-35 - InPen Smart Insulin System | 2021-02-01 The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injec |
| 62088-0000-36 - InPen Smart Insulin Delivery System | 2021-02-01 The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injec |