Patient Monitor M30 M30M-5PNXAH

GUDID 18800003428929

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

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 ID18800003428929
NIH Device Record Key4b8c7ac3-2013-48bd-89d5-66b15485dd1c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Monitor M30
Version Model NumberM30
Catalog NumberM30M-5PNXAH
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
GS118800003428929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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 Date2019-08-08

On-Brand Devices [Patient Monitor M30]

18800003428929The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasiv
18800003427847M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive bl
18800003427205The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasiv

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