FDA.reportPublic FDA data

Virtual by Volk Telemedicine Software

Primary DI
00811608019703
Brand
Virtual by Volk Telemedicine Software
Company
VOLK OPTICAL INC.
Model
VTELEMED
Published
2021-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00811608019703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608019703008116080197038116080197030811608019703

GMDN Terms#

Term, Definition table
TermDefinition
Multidisciplinary medical image management softwareA software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). Also referred to as an operating room (OR) integration software, it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.

Contacts#

Phone, Email table
PhoneEmail
440-942-6161snigdha.katragadda@volk.com

Regulatory Flags#

DUNS number
071125835
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00811608019970Mounting Kit, for Kaps SOM62121722026-04-27
00811608019987ROLS Adapter Kit, for Kaps122692026-04-27
00811608019994Single Use GonioPro Surgical Lens Sample Box (VSGSAMPLEBOX)VSGSAMPLEBOX2026-04-07
00811608012872SuperMacula VIT (VSMACVIT)VSMACVIT2016-09-29
00811608012889Central Retinal Vit (VCRLVIT)VCRLVIT2016-09-29
00811608012896Mini Quad VIT (VMQVIT)VMQVIT2016-09-29
00811608012902Dynaview 156 VIT (VDVVIT)VDVVIT2016-09-29
00811608012919Mini Quad XL VIT (VMQXLVIT)VMQXLVIT2016-09-29
00811608012971Central Retinal SSV (VCRLVITSSV)VCRLVITSSV2016-09-28
00811608012988Mini Quad SSV (VMQVITSSV)VMQVITSSV2016-09-28
00811608012995Mini Quad XL VIT SSV (VMQXLVITSSV)VMQXLVITSSV2016-09-29
00811608013053HRX Vit (VHRXVIT)VHRXVIT2016-09-29
00811608013060HRX SSV Vit (VHRXVITSSV)VHRXVITSSV2016-09-28
00811608013305HR Direct 1X Vit (VHRD1XACS)VHRD1XACS2016-09-29
00811608013312HR Direct 1X NSR Vit (VHRD1XNSRACS)VHRD1XNSRACS2016-09-29
00811608013336HR Direct Bi-Concave (VHRDBCACS)VHRDBCACS2016-09-29
00811608013343HR Direct HighMag Vit (VHRDHMACS)VHRDHMACS2016-09-29
00811608013350HR Direct HM NSR Vit (VHRDHMNSRACS)VHRDHMNSRACS2016-09-29
00811608013183Flat SSV ACS (VFLATSSVACS)VFLATSSVACS2016-09-29
0081160801319015 Prism SSV ACS (VPRISMSSVACS)VPRISMSSVACS2016-09-29

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
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2025-11-17
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