NOU

Product Code: NOU


Products Classified as NOU

166Continuous, Ventilator, Home UseContinuous Ventilator.

Total Product Life Cycle (TPLC) Devices

166Continuous, Ventilator, Home UseContinuous Ventilator.

FDA Consensus Standards

Continuous, Ventilator, Home Use [36713]21 CFR §868.5895 🔎
Continuous, Ventilator, Home Use [36710]21 CFR §868.5895 🔎
Continuous, Ventilator, Home Use [36711]21 CFR §868.5895 🔎
Continuous, Ventilator, Home Use [33189]21 CFR §868.5895 🔎
Continuous, Ventilator, Home Use [38929]21 CFR §868.5895 🔎

Pre-market Notifications for NOU

K193586Vivo 45 LSBreas Medical AB
K160481Vivo 60BREAS MEDICAL AB
K123144VIVO 50GE HEALTHCARE, BREAS MEDICAL AB
K034032PLV CONTINUUM VENTILATOR, MODEL P2000RESPIRONICS CALIFORNIA, INC.
K022750PLV CONTINUUM VENTILATOR, MODEL P1000RESPIRONICS CALIFORNIA, INC.
K021981IVENT 201 PORTABLE VENTILATORVERSAMED LTD.

Global Unique Device Identification Database

00606959022829CONTINUOUS, VENTILATOR, HOME USE
00606959022782CONTINUOUS, VENTILATOR, HOME USE
00606959022737CONTINUOUS, VENTILATOR, HOME USE
00606959022713CONTINUOUS, VENTILATOR, HOME USE
00606959022683CONTINUOUS, VENTILATOR, HOME USE
00606959022089CONTINUOUS, VENTILATOR, HOME USE
00606959053984CONTINUOUS, VENTILATOR, HOME USE
00606959053533CONTINUOUS, VENTILATOR, HOME USE
00606959052482CONTINUOUS, VENTILATOR, HOME USE
00606959052420CONTINUOUS, VENTILATOR, HOME USE
00606959052352CONTINUOUS, VENTILATOR, HOME USE
00606959052246CONTINUOUS, VENTILATOR, HOME USE
00606959050723CONTINUOUS, VENTILATOR, HOME USE
00606959050044CONTINUOUS, VENTILATOR, HOME USE
00606959050037CONTINUOUS, VENTILATOR, HOME USE

Maude Adverse Events

BATTERIE EXTERNE ASTRALRESMED LTD2020-02-13
ASTRAL 150 - FUKUDARESMED LTD2020-01-15
ASTRAL 150 DBL KIT FRARESMED LTD2020-01-14
ASTRAL 150 - AMERRESMED LTD2020-01-13
ASTRAL 150 - FUKUDARESMED LTD2020-01-13
ASTRAL 150 DBL KIT - EUR4RESMED LTD2020-01-13
ASTRAL 100 - EUR1RESMED LTD2020-01-13
ASTRAL 150 - FUKUDARESMED LTD2020-01-13
ASTRAL 150 - AMERRESMED LTD2020-01-13
ASTRAL 150 DBL KIT FRARESMED LTD2020-01-12
ASTRAL 150 - FUKUDARESMED LTD2020-01-09
ASTRAL 150 - AMERRESMED LTD2020-01-09
ASTRAL 150 - FUKUDARESMED LTD2020-01-09
ASTRAL 150 - AMERRESMED LTD2020-01-09
ASTRAL 150 DBL KIT FRARESMED LTD2019-11-27
ASTRAL 150 - FUKUDARESMED LTD2019-11-25
ASTRAL 150 DBL KIT - EUR4RESMED LTD2019-11-22
ASTRAL 150 DBL KIT - EUR4RESMED LTD2019-11-06
ASTRAL 150 - AMERRESMED LTD2019-10-16
ASTRAL 150 - DEURESMED LTD2019-09-17
ASTRAL 150 - AMERRESMED LTD2019-08-19
ASTRAL 150 - AMERRESMED LTD2019-08-19
ASTRAL 150 - APAC2RESMED LTD2019-08-14
ASTRAL 150 - APAC2RESMED LTD2019-08-14
ASTRAL 100 - APAC2RESMED LTD2019-08-14
ASTRAL 100 - APAC2RESMED LTD2019-08-14
ASTRAL 100 - APAC2RESMED LTD2019-08-14
ASTRAL 150 - APAC2RESMED LTD2019-08-14
ASTRAL 150 - APAC2RESMED LTD2019-08-14
ASTRAL 100 - APAC2RESMED LTD2019-08-14
ASTRAL 100 - APAC2RESMED LTD2019-08-14
ASTRAL 100 - APAC2RESMED LTD2019-08-14
ASTRAL 150 -EUR4RESMED LTD2019-08-14
ASTRAL 100 - APAC2RESMED LTD2019-08-14
ASTRAL 150 -EUR4RESMED LTD2019-08-14
ASTRAL 100 - AMERRESMED LTD2019-08-13
ASTRAL 150 - AMERRESMED LTD2019-08-13
ASTRAL 100 - AMERRESMED LTD2019-08-13
ASTRAL 100 - AMERRESMED LTD2019-08-13
BREAS VIVO 50BREAS MEDICAL AB2019-08-06
ASTRAL 150 - AMERRESMED LTD2019-07-15
ASTRAL 150 - AMERRESMED LTD2019-07-15
ASTRAL 150 - AMERRESMED LTD2019-07-15
ASTRAL 150 - AMERRESMED LTD2019-07-15
ASTRAL 150 - AMERRESMED LTD2019-07-14
BREAS VIVO 50BREAS MEDICAL AB2019-06-10
BREAS VIVO 50BREAS MEDICAL AB2019-05-08
BREAS VIVO 50BREAS MEDICAL AB2019-04-24
BREAS VIVO 50BREAS MEDICAL AB2019-03-28
BREAS VIVO 50BREAS MEDICAL AB2019-03-08
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