Product Code: BZD


Products Classified as BZD

66Ventilator, Non-continuous (respirator)Noncontinuous Ventilator (IPPB).

Total Product Life Cycle (TPLC) Devices

66Ventilator, Non-continuous (respirator)Noncontinuous Ventilator (IPPB).

FDA Consensus Standards

Ventilator, Non-Continuous (Respirator) [36713]21 CFR §868.5905 🔎
Ventilator, Non-Continuous (Respirator) [36710]21 CFR §868.5905 🔎
Ventilator, Non-Continuous (Respirator) [36711]21 CFR §868.5905 🔎
Ventilator, Non-Continuous (Respirator) [38929]21 CFR §868.5905 🔎
Ventilator, Non-Continuous (Respirator) [33225]21 CFR §868.5905 🔎
Ventilator, Non-Continuous (Respirator) [35891]21 CFR §868.5905 🔎
Ventilator, Non-Continuous (Respirator) [33582]21 CFR §868.5905 🔎
Ventilator, Non-Continuous (Respirator) [33435]21 CFR §868.5905 🔎

Pre-market Notifications for BZD

K212371F&P Evora Full Face MaskFisher & Paykel Healthcare Ltd
K212263Luna G3 BPAP System3B Medical, Inc.
K211155Auto CPAP SystemBMC Medical Co., Ltd.
K210386Magneto Nasal MaskRespironics, Inc.
K203601Innova Nasal Non-Vented MaskSleepnet Corporation
K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskSuzhou Yuyue Medical Technology Co., Ltd.
K203126S10 KirraResMed Pty Ltd
K201620Luna® G3 BPAP 25A3B Medical, Inc.
K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.
K200565GalapogosResMed Corp
K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.
K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (SmalFisher & Paykel Healthcare Ltd.
K193206WiZARD 510 Nasal MaskApex Medical Corp.
K192177SysMed S/TSysMed (China) Co., Ltd
K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)Fisher & Paykel Healthcare Ltd.

Global Unique Device Identification Database

00606959023116VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959023048VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959023031VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959023024VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959023017VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959023000VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022997VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022980VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022973VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022966VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022959VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022652VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022645VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022638VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
00606959022621VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Maude Adverse Events

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)RESPIRONICS, INC.2020-03-27
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL2020-03-22
AIR CURVE 10RESMED CORP.2020-03-20
ICON SERIES CPAPFISHER & PAYKEL HEALTHCARE LTD2020-03-18
DREAMSTATION AUTO CPAPRESPIRONICS, INC.2020-03-12
REMSTARRESPIRONICS, INC.2020-03-11
AIRSENSE 10 AUTOSET USA CORESMED LTD2020-03-10
AIRSENSE 10 AUTOSET USA CORESMED LTD2020-03-10
CPAPRESMED CORP.2020-03-04
CPAPRESMED CORP.2020-03-04
CPAPRESMED CORP.2020-03-04
F&P SLEEPSTYLE AUTO CPAPFISHER & PAYKEL HEALTHCARE LTD2020-02-27
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL.2020-02-24
CPAP NASAL MASKRESMED CORP.2020-02-21
CPAP NASAL MASKRESMED CORP.2020-02-21
AIRSENSE 10 AUTOSET USA TRIRESMED LTD2020-02-19
AIRSENSE 10 AUTOSET USA CORESMED LTD2020-02-19
AIRSENSE 10 AUTOSET USA CORESMED LTD2020-02-19
AIRSENSE 10 AUTOSET USA TRIRESMED LTD2020-02-19
DREAMSTATION AUTO CPAPRESPIRONICS, INC.2020-02-17
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL.2020-02-13
COMFORTGEL BLUE FULLRESPIRONICS INC2020-02-13
PHILIPS RESPIRONICS DREAM/WEAR UNDER THE NOSE NASAL MASKPHILIPS / RESPIRONICS, INC.2020-02-12
PHILIPS CPAP SYSTEM ONE REMSTAR AUTO A-FLEX MODEL 560 (SEE PICTURE)PHILIPS / RESPIRONICS, INC.2020-02-10
AIRFIT F20 MED SYS - EU1RESMED LTD2020-02-05
AIRSENSE 10 AUTOSET USA TRIRESMED LTD2020-02-05
AIRSENSE 10 AUTOSET USA TRIRESMED LTD2020-02-05
AIRFIT F20 MED SYS - EU1RESMED LTD2020-02-05
REMSTAR AUTO A-FLEX, SYSTEM ONE, 60 SERIES , GBRESPIRONICS, INC.2020-02-03
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL2020-01-28
INFANT FLOW SIPAPVYAIRE MEDICAL2020-01-27
DREAMSTATION AUTO CPAP W/HUMID, DOMRESPIRONICS INC2020-01-24
DREAMSTATION AUTO BIPAPRESPIRONICS, INC.2020-01-20
DREAMSTATION AUTO BIPAP W/HUMID, DOMRESPIRONICS INC2020-01-20
F&P SLEEPSTYLE AUTO CPAPFISHER & PAYKEL HEALTHCARE LTD2020-01-19
VITERA MASK FULL FACE MEDIUM A MODELFISHER & PAYKEL HEALTHCARE LTD2020-01-16
ICON SERIES CPAPFISHER & PAYKEL HEALTHCARE LTD2020-01-16
RESMED AIR SENSE S 10 AUTOSET CPAP MACHINERESMED LTD.2020-01-15
PACKAGE ASSEMBLY,INFANT FLOW,LPVYAIRE MEDICAL2020-01-15
BIPAP MACHINEPHILIPS RESPIRONICS / RESPIRONICS, INC.2020-01-14
ICON SERIES CPAPFISHER & PAYKEL HEALTHCARE LTD2020-01-13
ICON SERIES CPAPFISHER & PAYKEL HEALTHCARE LTD2020-01-13
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL2020-01-10
AIRFIT F30 SML SYS - AMERRESMED LTD2020-01-07
AIRFIT F30 SML SYS - AMERRESMED LTD2020-01-07
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONVYAIRE MEDICAL2020-01-07
F&P ESON 2 NASAL MASK MEDIUM A FOR CPAPFISHER & PAYKEL HEALTHCARE INC.2020-01-06
OBSOLETE S9 AUTOSET - RMD HCRESMED LTD2019-12-11
OBSOLETE S9 AUTOSET - RMD HCRESMED LTD2019-12-11
INFANT FLOW SIPAPVYAIRE MEDICAL2019-11-28

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