Mediana.CO.LTD

Address:132, Donghwagongdan-ro, Munmak-eup,Wonju-Si, Gangwon-do,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (10) Oximeter (DQA) (8) Thermometer, Electronic, Clinical (FLL) (8)

Premarket Exempt

Clear

Direct Supply - 18800003400567 Catalog Number : PA3DS-B0

Device Description : The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

Direct Supply - 18800003400574 Catalog Number : PA3DS-PB0

Device Description : The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

Patient Monitor V10 - 18800003407740 Catalog Number : V10M-2PXNRU

Device Description : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - sy

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : FLL, DQA, DXN

Prescription Use : Yes

Device Count : 1

Patient Monitor V10 - 18800003407757 Catalog Number : V10M-2PXNZU

Device Description : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - sy

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : FLL, DQA, DXN

Prescription Use : Yes

Device Count : 1

Patient Monitor V10 - 18800003407788 Catalog Number : V10M-2PXCRU

Device Description : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - sy

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : FLL, DQA, DXN

Prescription Use : Yes

Device Count : 1

Patient Monitor V10 - 18800003407795 Catalog Number : V10M-2PXCZU

Device Description : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - sy

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : FLL, DQA, DXN

Prescription Use : Yes

Device Count : 1

Patient Monitor V10 - 18800003408488 Catalog Number : V10M-3XXCRU

Device Description : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - sy

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : FLL, DQA, DXN

Prescription Use : Yes

Device Count : 1

Patient Monitor V10 - 18800003408495 Catalog Number : V10M-3XXCZU

Device Description : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - sy

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : FLL, DQA, DXN

Prescription Use : Yes

Device Count : 1

Patient Monitor V10 - 18800003408686 Catalog Number : V10M-3PXCRU

Device Description : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - sy

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : FLL, DQA, DXN

Prescription Use : Yes

Device Count : 1

Patient Monitor V10 - 18800003408693 Catalog Number : V10M-3PXCZU

Device Description : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - sy

Device Class : 2

Duns Number: 687879726

Premarket Exempt : No

Product Code : FLL, DQA, DXN

Prescription Use : Yes

Device Count : 1

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