AccessGUDID - DEVICE: PMD-200 System (07290017287348)

GUDID

Device Identifier (DI) Information

Brand Name: PMD-200 System
Version or Model: PMD200-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SYS-1FP-23
Company Name: MEDASENSE BIOMETRICS LTD

Primary DI Number: 07290017287348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532646234 *Terms of Use

Device Description: PMD-200 monitor with NOL Nociception Level Technology

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QVE	Adjunctive Pain Measurement Device For Anesthesiology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN210022	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8050aaf9-45f8-429d-8759-e7d003407aa1
Public Version Date: November 23, 2023
Public Version Number: 1
DI Record Publish Date: November 15, 2023