Visionflex

GUDID 09352527001314

ProEX Telehealth Hub System FSC2 - NTSC - CLIN - v3

VISIONFLEX PTY. LTD.

Patient monitoring system module, data memory

• Primary Device ID: 09352527001314
• NIH Device Record Key: 619cc0f6-d24f-44b7-800a-04a3491c0aee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visionflex
• Version Model Number: VFPROEX24.03
• Company DUNS: 752219480
• Company Name: VISIONFLEX PTY. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09352527001192 [Primary]
GS1	09352527001314 [Package]; Contains: 09352527001192; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• OUG: Medical Device Data System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-01
• Device Publish Date: 2021-02-19

On-Brand Devices [Visionflex ]

• 09352527000775: GEIS Camera (General Examination Imaging System) is a handheld device that can capture medical g
• 09352527000669: ProEX Mobile Telehealth Hub
• 09352527000614: ProEX Telehealth Hub System Standard - CLINICIAN v3
• 09352527000607: ProEX Telehealth Hub System FSC3 CLINICIAN v2
• 09352527000591: ProEX Telehealth Hub System FSC2 CUSTOMER SUPPLIED - CLINICIAN v2
• 09352527000584: ProEX Telehealth Hub System FSC2 - NTSC - CLINICIAN v2
• 09352527000577: ProEX Telehealth Hub System GEIS - CLINICIAN v2
• 09352527000560: ProEX Telehealth Hub System FSC2 PAL - CLINICIAN v2
• 09352527000553: The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all
• 09352527001314: ProEX Telehealth Hub System FSC2 - NTSC - CLIN - v3
• 09352527001307: ProEX Telehealth Hub System GEIS - CLIN - v3
• 09352527001161: ProEX Telehealth Hub System Standard - CLIN - v3