Address:1800 E. Wilshire Avenue,Santa Ana,CA,92705,US
Device Description : The Nihon Kohden NKV-550-S is a continuous use ventilator that is designed to me The Nihon Kohden NKV-550-S is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).
Device Class : 2
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Nihon Kohden NKV-550-U is a continuous use ventilator that is designed to me The Nihon Kohden NKV-550-U is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for neonatal through adult patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).
Device Class : 2
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Nihon Kohden NKV-550-N is a continuous use ventilator that is designed to me The Nihon Kohden NKV-550-N is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for neonatal through pediatric patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).
Device Class : 2
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Nihon Kohden Graphic User Interface is a display that is used with all NKV-5 The Nihon Kohden Graphic User Interface is a display that is used with all NKV-550 Ventilator configurations. The Graphical User Interface may be provided to users as a replacement or as a second Graphical User Interface.
Device Class : 2
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Nihon Kohden NKV-330 Ventilator is an assist ventilator intended to support The Nihon Kohden NKV-330 Ventilator is an assist ventilator intended to support adult and pediatric patients who are breathing spontaneously and require a tidal volume of 100mL or more with an oxygen concentration of 21 to 100%. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications.
Device Class : 2
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NPPV cap-ONE Mask Set (Large) is used with the TG-980P CO2 sensor kit. The M The NPPV cap-ONE Mask Set (Large) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.
Device Class :
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NPPV cap-ONE Mask Set (Medium) is used with the TG-980P CO2 sensor kit. The The NPPV cap-ONE Mask Set (Medium) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.
Device Class :
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NPPV cap-ONE Mask Set (Small) is used with the TG-980P CO2 sensor kit. The M The NPPV cap-ONE Mask Set (Small) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.
Device Class :
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The exhalation port is intended to be part of a single limb breathing circuit fr The exhalation port is intended to be part of a single limb breathing circuit from the NKV-330 ventilator. The exhalation port provides a fixed leak and connection for pressure measurement.
Device Class :
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NPPV cap-ONE Mask Set (Extra Small) is used with the TG-980P CO2 sensor kit. The NPPV cap-ONE Mask Set (Extra Small) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.
Device Class :
Duns Number: 079962037
Premarket Exempt : No
Prescription Use : Yes