| Primary Device ID | 62088-0000-34 |
| NIH Device Record Key | fab0c88a-a041-4d4b-8d63-b3f09346d58c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InPen Smart Insulin Delivery System |
| Version Model Number | Novo - Blue |
| Catalog Number | InPen-100NN-BL / MMT-105NNBL |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10862088000344 [Primary] |
| NDC/NHRIC | 62088-0000-34 [Secondary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-02-01 |
| Device Publish Date | 2017-05-01 |
| 62088-0000-36 | The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age |
| 62088-0000-34 | The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age |
| 62088-0000-33 | The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age |
| 62088-0000-32 | The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age |
| 62088-0000-31 | The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age |