6 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
FDA Enforcement
Class II
·Completed·Vyaire Medical·June 21, 2023
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
FDA Enforcement
Class II
·Completed·Vyaire Medical·June 21, 2023
AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
FDA Enforcement
Class II
·Terminated·Vyaire Medical·September 6, 2017
bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high pressure inlet. An electronic mixer valve provides for the operator-set concentration. Gas is supplied to the patient via the microprocessor controlled inspiratory valve.
FDA Enforcement
Class II
·Terminated·Vyaire Medical·March 11, 2020
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
FDA Enforcement
Class II
·Completed·Vyaire Medical·December 13, 2023
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
FDA Enforcement
Class II
·Completed·Vyaire Medical·December 13, 2023