FDA.reportPublic FDA data

Professional high-flow respiratory unit

Definition
A mains electricity (AC-powered) device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen to a patient as therapy for a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. The gases are delivered as part of noninvasive ventilation (NIV) to the patient's airway via the nose/mouth or a tracheostoma. It consists of a gas flow generator, a heating element, and humidification chamber. It is intended to be used by a healthcare provider on a spontaneously breathing patient.
GUDID devices
66
Last updated
2022-10-04 06:48:55

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841737102458VapothermVAPOTHERM, INC.HVT-UKIT-IL2022-09-26
00841737105510VapothermVAPOTHERM, INC.HVT-UKIT-DISS-EU2022-09-26
00841737102427VapothermVAPOTHERM, INC.HVT20-UNIT-VTU-OUS2022-08-29
00841737102434VapothermVAPOTHERM, INC.HVT-VTU-OUS2022-08-29
10841737102035VapothermVAPOTHERM, INC.430005762022-05-31
00841737105466VapothermVAPOTHERM, INC.HVT-UKIT-GB2022-01-27
00841737105473VapothermVAPOTHERM, INC.HVT-UKIT-NIST2022-01-27
00841737105435VapothermVAPOTHERM, INC.OAM-MAS-UKIT-PH2021-12-13
00841737105442VapothermVAPOTHERM, INC.PFH-UKIT-C-ZA2021-12-13
00841737105459VapothermVAPOTHERM, INC.OAM-NEL-UKIT-PH2021-12-13
00841737105343VapothermVAPOTHERM, INC.HVT20-STAND2021-11-15
00841737105398VapothermVAPOTHERM, INC.HVT-UKIT-US2021-11-15
00841737105404VapothermVAPOTHERM, INC.PF-ADPC-HIGH42021-11-15
00841737105428VapothermVAPOTHERM, INC.PF-ADPC-LOW42021-11-15
00841737105305VapothermVAPOTHERM, INC.HVT-BAT2021-11-11
00841737105312VapothermVAPOTHERM, INC.OAM-MAS-UKIT-IN2021-11-11
00841737105329VapothermVAPOTHERM, INC.OAM-NEL-UKIT-IN2021-11-11
00841737103769VapothermVAPOTHERM, INC.3003011-PH2021-11-04
00841737105046VapothermVAPOTHERM, INC.3003034-PH2021-11-04
00841737105053VapothermVAPOTHERM, INC.AAA-1-PH2021-11-04
00841737105060VapothermVAPOTHERM, INC.MA1700-PH2021-11-04
00841737105077VapothermVAPOTHERM, INC.MI1300B-PH2021-11-04
00841737105084VapothermVAPOTHERM, INC.MI1300-PH2021-11-04
00841737105091VapothermVAPOTHERM, INC.MN1100B-PH2021-11-04
00841737105107VapothermVAPOTHERM, INC.MN1100A-PH2021-11-04
00841737105114VapothermVAPOTHERM, INC.MP1500-PH2021-11-04
00841737105121VapothermVAPOTHERM, INC.MPS1500-PH2021-11-04
00841737105138VapothermVAPOTHERM, INC.PF-DPC-HIGH-PH2021-11-04
00841737105145VapothermVAPOTHERM, INC.PF-DPC-LOW-PH2021-11-04
00841737105152VapothermVAPOTHERM, INC.PF-OAM-MAS-PH2021-11-04
00841737105169VapothermVAPOTHERM, INC.PF-OAM-NEL-PH2021-11-04
00841737105176VapothermVAPOTHERM, INC.PF-STAND-GCX-PH2021-11-04
00841737105183VapothermVAPOTHERM, INC.PF-PLUS-PH2021-11-04
00841737105190VapothermVAPOTHERM, INC.PF-WBA-PH2021-11-04
00841737105206VapothermVAPOTHERM, INC.PROSOFT-INF-PH2021-11-04
00841737105213VapothermVAPOTHERM, INC.PROSOFT-INT-INF-PH2021-11-04
00841737105220VapothermVAPOTHERM, INC.PROSOFT-NEO-PH2021-11-04
00841737105237VapothermVAPOTHERM, INC.PROSOFT-PED-AS-PH2021-11-04
00841737105244VapothermVAPOTHERM, INC.PROSOFT-PED-S-PH2021-11-04
00841737105251VapothermVAPOTHERM, INC.PROSOFT-PRE-PH2021-11-04
00841737105268VapothermVAPOTHERM, INC.PROSOFT-XL-PH2021-11-04
00841737105275VapothermVAPOTHERM, INC.SOLO1300-PH2021-11-04
00841737105299VapothermVAPOTHERM, INC.PROSOFT-ADULT-PH2021-11-04
10841737105029VapothermVAPOTHERM, INC.PF-DPC-LOW22021-09-27
10841737105036VapothermVAPOTHERM, INC.PF-DPC-HIGH22021-09-27
10841737104985VapothermVAPOTHERM, INC.PF-ADPC-HIGH32021-08-31
10841737104992VapothermVAPOTHERM, INC.PF-ADPC-LOW32021-08-31
00841737104872VapothermVAPOTHERM, INC.PF-DPC-HIGH-AJ52021-08-24
00841737104896VapothermVAPOTHERM, INC.PF-DPC-HIGH32021-08-24
00841737104902VapothermVAPOTHERM, INC.PF-DPC-HIGH-AJ62021-08-24
00841737104919VapothermVAPOTHERM, INC.PF-DPC-HIGH42021-08-24
00841737104926VapothermVAPOTHERM, INC.PF-DPC-LOW-AK52021-08-24
00841737104933VapothermVAPOTHERM, INC.PF-DPC-LOW32021-08-24
00841737104940VapothermVAPOTHERM, INC.PF-DPC-LOW-AK62021-08-24
00841737104957VapothermVAPOTHERM, INC.PF-DPC-LOW42021-08-24
10841737104961VapothermVAPOTHERM, INC.PF-DPC-HIGH-BAG-MX2021-08-24
10841737104978VapothermVAPOTHERM, INC.PF-DPC-LOW-BAG-MX2021-08-24
00841737104728VapothermVAPOTHERM, INC.31015912021-07-13
00841737104735VapothermVAPOTHERM, INC.430005702021-07-13
00841737104742VapothermVAPOTHERM, INC.430005382021-07-13
00841737104759VapothermVAPOTHERM, INC.430005942021-07-13
00841737104766VapothermVAPOTHERM, INC.430005952021-07-13
00841737104773VapothermVAPOTHERM, INC.430002082021-07-13
00841737104582VapothermVAPOTHERM, INC.PF-WBA-IN2021-06-22
09420012422248Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDPT100US2016-09-08
09420012422347Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDPT101US2016-09-08