| Primary Device ID | 20846446003403 |
| NIH Device Record Key | 2aa912e8-2d83-4140-8163-19276ca37449 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3100 HFOV |
| Version Model Number | 766897 |
| Catalog Number | 766897 |
| Company DUNS | 830432451 |
| Company Name | Carefusion Corporation |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 00846446003409 [Unit of Use] |
| GS1 | 20846446003403 [Primary] |
| LSZ | Ventilator, High Frequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-09-24 |
| 20846446003410 | CAP/DIAPHRAGM SET, BOX OF 4, 3100A/B |
| 20846446003403 | BELLOWS/WATER TRAP BOX4 |
| 20846446003335 | ASSY, EXPIRATORY FILTER, BOXED |
| 10846446003574 | TUBE SET, NON-FILTERED CIRCUIT |
| 10846446010329 | HOSE ASSY, PRES, AIR, YEL, DISS, 2FT |
| 10846446003581 | TUBE SET, FILTERED CIRCUIT ONLY |
| 10846446003161 | ASSY,INSPIRATORY FILTER,BOXED |
| 10846446002317 | KIT, BLENDER |
| 10846446062502 | KIT, BLENDER BRACKET |
| 10846446060997 | CIRCUIT PORT ADAPTOR |
| 10846446015355 | HOSE ASSEMBLY, MEDICAL AIR, YELLOW |
| 10846446015348 | HOSE ASSY, O2, NON-CONDUCTIVE, GRN |
| 10846446003628 | EXHALED GAS DEFLECTOR 3100A/3100B |