FDA.reportPublic FDA data

Visionflex

Primary DI
09352527000553
Brand
Visionflex
Company
VISIONFLEX PTY. LTD.
Model
VFPROEX21.02
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.
Published
2020-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09352527000683PackageGS11In Commercial Distribution
09352527000553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352527000683093525270006839352527000683
09352527000553093525270005539352527000553

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, data memoryA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
752219480
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09352527001185Visionflex VFPROEX23.032021-02-19
09352527001192Visionflex VFPROEX24.032021-02-19
09352527001161Visionflex VFPROEX21.032021-02-19
09352527001307Visionflex VFPROEX23.032021-02-19
09352527001314Visionflex VFPROEX24.032021-02-19
09352527000560Visionflex VFPROEX22.022020-08-17
09352527000577VisionflexVFPROEX23.022020-08-17
09352527000584Visionflex VFPROEX24.022020-08-17
09352527000591VisionflexVFPROEX25.022020-08-17
09352527000607Visionflex VFPROEX26.022020-08-17
09352527000614VisionflexVFPROEX21.032020-08-17
09352527000669Visionflex VFPROEXMOBILE1.012020-08-17
09352527000775Visionflex VFGEISCAM1.042020-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04