Home GUDID 07290017287232 PMD-200 System
Primary DI 07290017287232
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
OTC false
Sterile false
Single use false 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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 07290017287348 PMD-200 System PMD200-2 SYS-1FP-23 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
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 07290017287348 PMD-200 System 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
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