Home GUDID 07290017287027
PMD-200 Single Use Sensor
Primary DI 07290017287027
Brand PMD-200 Single Use Sensor
Company MEDASENSE BIOMETRICS LTD
Model MEK-0002
Catalog number MEK-0002
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 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 07290017287027 Package GS1 20 In Commercial Distribution 07290017287034 Package GS1 10 In Commercial Distribution 07290017287201 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290017287027 07290017287027 7290017287027 07290017287034 07290017287034 7290017287034 07290017287201 07290017287201 7290017287201
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 Temperature 10 Degrees Celsius 35 Degrees Celsius Storage Environment Temperature -10 Degrees Celsius 50 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 true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true 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 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
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