PMD-200 System

Basic Information

• Brand Name: PMD-200 System
• Primary DI: 07290017287348
• Version / Model: PMD200-2
• Catalog Number: SYS-1FP-23
• Company Name: MEDASENSE BIOMETRICS LTD
• Labeler DUNS: 532646234
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-15
• Public Version: 1
• Public Version Date: 2023-11-23
• Public Version Status: New
• Public Device Record Key: 8050aaf9-45f8-429d-8759-e7d003407aa1

Device Description

PMD-200 monitor with NOL Nociception Level Technology

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QVE	Adjunctive Pain Measurement Device For Anesthesiology	Anesthesiology	868.2200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64495	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07290017287232	GS1
Primary	07290017287348	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN210022	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal