Personal Kinetigraph (PKG)

GUDID 09369998208654

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.

GKC MANUFACTURING PTY LTD

Neuromuscular motion disorder ambulatory recorder/analyser

• Primary Device ID: 09369998208654
• NIH Device Record Key: 138cfe7e-e995-4be8-b727-c710265d3e52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Personal Kinetigraph (PKG)
• Version Model Number: GKC-2000
• Company DUNS: 742903370
• Company Name: GKC MANUFACTURING PTY LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09369998107773 [Primary]
GS1	09369998208654 [Package]; Contains: 09369998107773; Package: Carry Case [10 Units]; In Commercial Distribution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-11-08

On-Brand Devices [Personal Kinetigraph (PKG) ]

• 09369998000562: The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 dev
• 09369998040162: The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms
• 09369998208654: The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms
• 09359011000310: The PKG Smart Charger is a portable charging station to be used in conjunction with 2000-LOG-004
• 09359011000303: The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms
• 09359011000297: The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 dev
• 09359011000280: The Personal KinetiGraph (PKG) is intended to quantify kinematics of movement disorder symptoms
• 09359011000327: The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 dev