Personal Kinetigraph (PKG)

Primary DI
09369998208654
Brand
Personal Kinetigraph (PKG)
Company
GKC MANUFACTURING PTY LTD
Model
GKC-2000
Device description
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.
Published
2017-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09369998208654PackageGS110In Commercial Distribution
09369998107773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09369998208654093699982086549369998208654
09369998107773093699981077739369998107773

GMDN Terms#

Term, Definition table
TermDefinition
Neuromuscular motion disorder ambulatory recorder/analyserAn 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
742903370
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09369998308569Personal Kinetigraph (PKG)2001-CHG-DOC-US2019-04-25
09359011000297Personal KinetiGraph (PKG)2022-CHG-DOC-V1.22023-10-20
09359011000327Personal KinetiGraph (PKG)2022-CHG-DOC-UNI2024-02-16
09359011000280Personal KinetiGraph (PKG)2023-LOG-G32023-10-23
09359011000303Personal Kinetigraph (PKG) 2000-LOG-0042023-10-20
09359011000310Personal KinetiGraph (PKG)2022-CHG-DOC-0042023-10-20
09369998107773Personal Kinetigraph (PKG) GKC-20002017-11-08
09369998040162Personal Kinetigraph (PKG)GKC-20092019-04-26
09369998000562Personal Kinetigraph (PKG)2001-CHG-DOC-US2019-04-25