Patient Monitor V10 V10M-3PXCZU

GUDID 18800003408693

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

Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID18800003408693
NIH Device Record Key78268c30-83f0-4cc8-8fde-5c0ca295f086
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Monitor V10
Version Model NumberV10
Catalog NumberV10M-3PXCZU
Company DUNS687879726
Company NameMediana.CO.LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118800003408693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2019-02-07

On-Brand Devices [Patient Monitor V10]

18800003408891The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
18800003408884V10: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, dia
18800003408693The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
18800003408686The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
18800003408495The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
18800003408488The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
18800003407795The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
18800003407788The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
18800003407757The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
18800003407740The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli

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