Personal KinetiGraph (PKG)

GUDID 09359011000280

Neuromuscular motion disorder ambulatory recorder/analyser

Primary Device ID	09359011000280
NIH Device Record Key	f6b3a3ab-1952-408f-b696-ad748c905b5b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Personal KinetiGraph (PKG)
Version Model Number	2023-LOG-G3
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 Issuing Agency	Device ID
GS1	09359011000280 [Primary]

Steralize Prior To Use	false
Device Is Sterile	false

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