Product code LSZ
- Device name
- Ventilator, High Frequency
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P850064S058 | LifePulse High Frequency Ventilator (LifePulse HFV) Model 204 | Bunnell, Inc. | 2026-05-07 |
| P850064S055 | LifePulse High Frequency Ventilator (HFV) | Bunnell, Inc. | 2025-07-25 |
| P890057S029 | MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR | ZOLL Medical Corporation | 2025-07-23 |
| P890057S027 | 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator | ZOLL Medical Corporation | 2024-11-15 |
| P850064S054 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2024-09-19 |
| P850064S052 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2024-06-21 |
| P890057S028 | 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator | ZOLL Medical Corporation | 2024-02-20 |
| P850064S053 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2023-12-28 |
| P850064S051 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2023-12-28 |
| P850064S050 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2023-05-31 |
| P850064S049 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2023-02-06 |
| P890057S025 | Model 3100A/B High Frequency Oscillatory Ventilator | ZOLL Medical Corporation | 2022-07-22 |
| P850064S047 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2022-03-31 |
| P850064S045 | Life Pulse High Frequency Ventilator | Bunnell, Inc. | 2021-10-13 |
| P850064S046 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2021-06-25 |
| P850064S044 | Life Pulse High Frequency Ventilator | Bunnell, Inc. | 2021-02-24 |
| P850064S043 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2020-11-25 |
| P850064S040 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2020-02-14 |
| P850064S042 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2019-12-13 |
| P850064S041 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2019-11-22 |
| P850064S039 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2019-06-14 |
| P850064S038 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2018-11-19 |
| P850064S037 | Model 203 Life Pulse High Frequency Ventilator | Bunnell, Inc. | 2018-10-19 |
| P850064S036 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2018-04-27 |
| P850064S035 | LifePulse High Frequency Ventilator | Bunnell, Inc. | 2017-12-20 |
| P850064S034 | Life Pulse High Frequency Ventilator | Bunnell, Inc. | 2017-07-06 |
| P850064S032 | LIFE PULSE HIGH FREQUENCY VENTILATOR | Bunnell, Inc. | 2017-04-24 |
| P850064S030 | LIFE PULSE HIGH FREQUENCY VENTILATOR | Bunnell, Inc. | 2016-12-23 |
| P850064S033 | LIFE PULSE HIGH FREQUENCY VENTILATOR | Bunnell, Inc. | 2016-08-18 |
| P850064S031 | MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR | Bunnell, Inc. | 2016-05-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10190752155312 | 3100A HFOV | VYAIRE MEDICAL, INC. | 2025-07-16 |
| 20190752201061 | 3100A HFOV | VYAIRE MEDICAL, INC. | 2025-07-16 |
| 10190752201019 | 3100 HFOV | VYAIRE MEDICAL, INC. | 2024-11-05 |
| 10190752201576 | 3100A HFOV | VYAIRE MEDICAL, INC. | 2024-08-12 |
| 10190752200760 | 3100A HFOV | VYAIRE MEDICAL, INC. | 2024-08-12 |
| 10190752200746 | 3100A HFOV | VYAIRE MEDICAL, INC. | 2024-08-12 |
| 10190752148857 | 3100 HFOV | VYAIRE MEDICAL, INC. | 2021-03-05 |
| 10190752148871 | 3100 HFOV | VYAIRE MEDICAL, INC. | 2021-03-05 |
| 10190752148833 | 3100A HFOV | VYAIRE MEDICAL, INC. | 2021-01-12 |
| 10846446005868 | 3100A/B | Carefusion Corporation | 2017-05-01 |
| 10846446005776 | 3100A/B | Carefusion Corporation | 2017-05-01 |
| 00616120000082 | Bunnell | BUNNELL, INCORPORATED | 2017-03-30 |
| 10616120000072 | LifePort | BUNNELL, INCORPORATED | 2016-12-29 |
| 10846446018738 | 3100A HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446018974 | 3100A HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446019018 | 3100A HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446060997 | 3100 HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446015355 | 3100 HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446015348 | 3100 HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446005394 | 3100A HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446003628 | 3100 HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446003543 | 3100B HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446003468 | 3100B HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446003284 | 3100A HFOV | Carefusion Corporation | 2014-09-24 |
| 10846446003079 | 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) | Carefusion Corporation | 2014-09-24 |
| 10846446003024 | 3100A HFOV | Carefusion Corporation | 2014-09-24 |
| 10616120000065 | LifePort | BUNNELL, INCORPORATED | 2014-09-24 |
| 10616120000058 | LifePort | BUNNELL, INCORPORATED | 2014-09-24 |
| 10616120000041 | LifePort | BUNNELL, INCORPORATED | 2014-09-24 |
| 10616120000034 | LifePort | BUNNELL, INCORPORATED | 2014-09-24 |