| Primary Device ID | 10190752158733 |
| NIH Device Record Key | 590ae81f-47b6-4242-a537-988a16b216ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3100 HFOV |
| Version Model Number | 772793 |
| Catalog Number | 772793 |
| Company DUNS | 080456871 |
| Company Name | VYAIRE MEDICAL, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752158733 [Primary] |
| LSZ | VENTILATOR, HIGH FREQUENCY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-16 |
| Device Publish Date | 2021-02-08 |
| 10190752181472 | CIRCUIT PORT ADAPTER FOR GAS SAMPLING |
| 10190752160804 | MICROBLENDER,W/2'/3' H,H/L,HFOV |
| 10190752158900 | Tube Set, Filtered Patient Circuit |
| 10190752158894 | Tube Set, Non-Filtered Patient Circuit |
| 10190752158733 | EXHALED GAS DEFLECTOR |
| 10190752155381 | Scavenger for 3100A / 3100B High Frequency Oscillatory Ventilators |
| 10190752176218 | RETAINER PWR CORD INSTRUMENT |
| 10190752155213 | KIT, 3100 BLENDER BRACKET |
| 50190752148879 | Expiratory Filter for Patient Circuit |
| 50190752148855 | Inspiratory Filter for Patient Circuit |
| 10190752201019 | Tube Set, Filtered Patient Circuit |