MEDIANA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10001168501000116850MEDIANA USA, INC.1Y2026-01-014034 Enterprise Way, Suite 160 Flowery Branch GA US 30542

PMN#

V10

2017-12-15

Mediana Co., Ltd.

DT-100

2017-02-24

Mediana Co., Ltd.

V10

2016-08-25

MEDIANA CO., LTD

FM20

2011-11-08

MEDIANA CO., LTD.

F10

2011-06-24

MEDIANA CO., LTD.

GUDID#

Patient Monitor V10 - V10: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.

Mediana.CO.LTD

2019-02-01

Direct Supply - The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-1 is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate and temperature for adult patients in all hospital areas, and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.

Mediana.CO.LTD

2016-09-26

Direct Supply - The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-1 is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate and temperature for adult patients in all hospital areas, and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.

Mediana.CO.LTD

2016-09-26

Patient Monitor M30 - The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), capnography (EtCO2 and InCO2) temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The M30 is suitable for continuous operation.

Mediana.CO.LTD

2019-08-08

Patient Monitor M30 - M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), capnography (EtCO2 and InCO2) temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The M30 is suitable for continuous operation.

Mediana.CO.LTD

2019-08-08

Patient Monitor M30 - The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), capnography (EtCO2 and InCO2) temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The M30 is suitable for continuous operation.

Mediana.CO.LTD

2019-08-08

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