| Primary Device ID | B3688008100310 |
| NIH Device Record Key | 3e5839d6-82eb-478e-9708-fbcd74d1618f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MGC Diganostics |
| Version Model Number | 800810-031 |
| Company DUNS | 094045622 |
| Company Name | MEDICAL GRAPHICS CORPORATION |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
|---|---|
| HIBCC | B3688008100310 [Primary] |
| BZL | Computer, Oxygen-Uptake |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-19 |
| Device Publish Date | 2018-06-18 |
| 00810016250555 - Medical Graphics | 2023-07-26 SW Ascent 2.0 |
| 00810016250579 - Medical Graphics | 2023-07-26 SW ASCENT 2.0 DOWNLOAD |
| 00810016250616 - Medical Graphics | 2023-06-22 Parallel Nose Clips -Case of 100 pcs |
| 536723004 - MGC Diagnostics | 2020-01-13 FILTER KIT 4 |
| 00810016251156 - MGC Diagnotics | 2019-06-10 PREVENT II FILTER-ROUND-WHITE |
| 00810016251163 - MGC Diagnostics | 2019-06-10 PREVENT II FILTER-ROUND-YELLOW |
| 00810016251187 - MGC Diagnostics | 2019-06-10 PREVENT II FILTER-ROUND-PINK |
| 00810016251194 - MGC Diagnostics | 2019-06-10 PREVENT II FILTER-ROUND-BLUE |