Visionflex

Basic Information

• Brand Name: Visionflex
• Primary DI: 09352527000553
• Version / Model: VFPROEX21.02
• 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: fab71dc0-ca80-42cb-ac8f-8245bac2effd

Device Description

The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all over the world to confidently carry out detailed medical examinations on patients based in regional, remote, rural and urban areas.

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	09352527000553	GS1
Package	09352527000683	GS1	Box	1	In Commercial Distribution