AccessGUDID - DEVICE: Personal Kinetigraph (PKG) (09369998308569)

GUDID

Device Identifier (DI) Information

Brand Name: Personal Kinetigraph (PKG)
Version or Model: 2001-CHG-DOC-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GKC MANUFACTURING PTY LTD

Primary DI Number: 09369998308569
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 742903370 *Terms of Use

Device Description: The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
61125	Neuromuscular motion disorder ambulatory recorder/analyser	An assembly of devices intended for 24-hour recording of body movements of a patient affected by a neuromuscular kinetic disorder (e.g., Parkinson’s disease) for analysis. It consists of battery-powered, home-use, externally-worn (e.g., wrist, leg, head) patient motion sensors worn during activities of daily living, a computing device/software for data analysis, and the appropriate connection cables. Stored data is retrieved from the patient recorder and analysed to provide a report (e.g., bradykinesia and dyskinesia severity score).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2004cb54-b444-4410-8dcc-b97fa569b9d3
Public Version Date: July 23, 2024
Public Version Number: 3
DI Record Publish Date: April 25, 2019