AccessGUDID - DEVICE: PMD-200 Single Use Sensor (07290017287201)

GUDID

Device Identifier (DI) Information

Brand Name: PMD-200 Single Use Sensor
Version or Model: MEK-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MEK-0002
Company Name: MEDASENSE BIOMETRICS LTD

Primary DI Number: 07290017287201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532646234 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
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
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f6edeac-3fcc-413f-993b-a71896cd3cf8
Public Version Date: November 23, 2023
Public Version Number: 1
DI Record Publish Date: November 15, 2023