Visionflex

Basic Information

• Brand Name: Visionflex
• Primary DI: 09352527000577
• Version / Model: VFPROEX23.02
• Company Name: VISIONFLEX PTY. LTD.
• Labeler DUNS: 752219480
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-17
• Public Version: 1
• Public Version Date: 2020-08-25
• Public Version Status: New
• Public Device Record Key: a05bef9d-7943-41a9-b63c-f4cb7a0d2ee3

Device Description

ProEX Telehealth Hub System GEIS - CLINICIAN v2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUG	Medical Device Data System	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37324	Patient monitoring system module, data memory	A small unit that serves as a temporary store of data; typically patient related data given from other devices, e.g., patient monitors or analysers which are not connected to a network, or are in a transport phase. This data is stored in this module's memory for transfer to a permanent store, e.g., the patient's electronic journal. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09352527000577	GS1
Package	09352527000706	GS1	1	1	In Commercial Distribution