FDA.reportPublic FDA data

Visionflex

Primary DI
09352527001307
Brand
Visionflex
Company
VISIONFLEX PTY. LTD.
Model
VFPROEX23.03
Device description
ProEX Telehealth Hub System GEIS - CLIN - v3
Published
2021-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
09352527001307PackageGS11In Commercial Distribution
09352527001185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352527001307093525270013079352527001307
09352527001185093525270011859352527001185

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
09352527001185Visionflex VFPROEX23.032021-02-19
09352527001192Visionflex VFPROEX24.032021-02-19
09352527001161Visionflex VFPROEX21.032021-02-19
09352527001314Visionflex VFPROEX24.032021-02-19
09352527000553VisionflexVFPROEX21.022020-08-17
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
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
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
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105701ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105718ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105725ResponderRAULAND-BORG CORPORATIONOUG2025-06-24