Home GUDID 07290017287348 PMD-200 System
Primary DI 07290017287348
Brand PMD-200 System
Company MEDASENSE BIOMETRICS LTD
Model PMD200-2
Catalog number SYS-1FP-23
Device description PMD-200 monitor with NOL Nociception Level Technology
Published 2023-11-15
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name QVE Adjunctive Pain Measurement Device For Anesthesiology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVE Adjunctive Pain Measurement Device For Anesthesiology Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290017287232 Direct Marking GS1 0 07290017287348 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290017287232 07290017287232 7290017287232 07290017287348 07290017287348 7290017287348
GMDN Terms# Term, Definition table Term Definition Analgesia nociception index monitoring system An electrically-powered device designed to continuously detect and measure, noninvasively, pain-associated physiological parameters [e.g., heart rate, electrodermal activity (EDA), skin temperature] for the calculation and display of a nociceptive pain index value, typically to evaluate patient pain intensity for titration of analgesic medication during procedures involving anaesthesia. It consists of a bedside monitor with integrated software and skin surface sensors [e.g., photoplethysmograph, accelerometer, galvanic skin response (GSR) electrodes], typically placed on the patient’s finger.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 30 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 30 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Temperature -10 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 532646234 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290017287201 PMD-200 Single Use Sensor MEK-0002 MEK-0002 2023-11-15 07290017287294 PMD-200 Finger Probe FP200-2 PMD-FNP-21 2023-11-15 07290017287027 PMD-200 Single Use Sensor MEK-0002 MEK-0002 2023-11-15 07290017287249 PMD-200 Finger Probe FP200-2 PMD-FNP-21 2023-11-15 07290017287232 PMD-200 System PMD200-2 SYS-1FP-23 2023-11-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290017287201 PMD-200 Single Use Sensor MEDASENSE BIOMETRICS LTD QVE 2023-11-15 07290017287294 PMD-200 Finger Probe MEDASENSE BIOMETRICS LTD QVE 2023-11-15 07290017287027 PMD-200 Single Use Sensor MEDASENSE BIOMETRICS LTD QVE 2023-11-15 07290017287249 PMD-200 Finger Probe MEDASENSE BIOMETRICS LTD QVE 2023-11-15 07290017287232 PMD-200 System MEDASENSE BIOMETRICS LTD QVE 2023-11-15