Adding an additional supplier of the patient box standoffs that are used in both models of the patient box (312 and 314). The change proposed does not affect the performance of the patient box and thus the lifepulse high frequency ventilator is not affected. There is no change to the design or any labeling. The following manufacturing facility is affected by the change(s): bunnell incorporated, 436 lawndale drive, salt lake city, utah.
| Device | LifePulse High Frequency Ventilator |
| Classification Name | Ventilator, High Frequency |
| Generic Name | Ventilator, High Frequency |
| Applicant | BUNNELL, INC. |
| Date Received | 2018-10-25 |
| Decision Date | 2018-11-19 |
| PMA | P850064 |
| Supplement | S038 |
| Product Code | LSZ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Anesthesiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BUNNELL, INC. 436 Lawndale Dr. salt Lake City, UT 84115 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850064 | | Original Filing |
| S047 |
2022-03-07 |
30-day Notice |
| S046 |
2021-05-27 |
30-day Notice |
| S045 | | |
| S044 |
2021-01-28 |
30-day Notice |
| S043 |
2020-10-29 |
30-day Notice |
| S042 |
2019-11-15 |
30-day Notice |
| S041 |
2019-10-24 |
30-day Notice |
| S040 | | |
| S039 |
2019-02-27 |
135 Review Track For 30-day Notice |
| S038 |
2018-10-25 |
30-day Notice |
| S037 |
2018-09-20 |
30-day Notice |
| S036 |
2018-01-29 |
Real-time Process |
| S035 |
2017-10-02 |
Real-time Process |
| S034 |
2017-06-07 |
30-day Notice |
| S033 |
2016-07-22 |
30-day Notice |
| S032 |
2016-05-24 |
Real-time Process |
| S031 |
2016-02-24 |
Real-time Process |
| S030 |
2015-03-31 |
Normal 180 Day Track |
| S029 |
2015-02-18 |
30-day Notice |
| S028 |
2015-02-04 |
Normal 180 Day Track |
| S027 |
2014-08-25 |
Normal 180 Day Track No User Fee |
| S026 |
2014-01-27 |
30-day Notice |
| S025 |
2013-09-09 |
30-day Notice |
| S024 | | |
| S023 |
2013-06-10 |
Normal 180 Day Track |
| S022 | | |
| S021 |
2012-09-07 |
Normal 180 Day Track |
| S020 | | |
| S019 | | |
| S018 |
2010-02-22 |
Normal 180 Day Track |
| S017 |
2001-04-04 |
Normal 180 Day Track |
| S016 |
1999-09-10 |
Special (immediate Track) |
| S015 |
1998-10-21 |
Normal 180 Day Track |
| S014 |
1998-08-28 |
Special (immediate Track) |
| S013 | | |
| S012 |
1997-04-11 |
Special (immediate Track) |
| S011 |
1995-04-05 |
Normal 180 Day Track |
| S010 |
1994-08-05 |
Normal 180 Day Track |
| S009 |
1992-11-27 |
Normal 180 Day Track |
| S008 | | |
| S007 | | |
| S006 |
1991-08-01 |
Normal 180 Day Track |
| S005 |
1990-10-01 |
Normal 180 Day Track |
| S004 | | |
| S003 |
1989-07-24 |
Normal 180 Day Track |
| S002 |
1989-02-09 |
Normal 180 Day Track |
| S001 |
1988-09-19 |
Normal 180 Day Track |
NIH GUDID Devices