FDA.reportPublic FDA data

ViewHub®

Primary DI
06975339626167
Brand
ViewHub®
Company
MacroLux Medical Technology Co., Ltd.
Model
S13
Device description
ViewHub®, Video Processor, S13
Published
2024-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975339626164PackageGS11In Commercial Distribution
26975339626161PackageGS11In Commercial Distribution
06975339626167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697533962616416975339626164
2697533962616126975339626161
06975339626167069753396261676975339626167

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Regulatory Flags#

DUNS number
723490133
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975339621506BubbleViewC38-CS2026-08-14
06975339621513BubbleViewC38-CRS2026-08-14
06975339621520BubbleViewC50-CB2026-08-14
06975339621537BubbleViewC50-CBR2026-08-14
06975339621926BubbleViewC38-CS2026-08-14
06975339621933BubbleViewC38-CRS2026-08-14
06975339621964BubbleViewC50-CB2026-08-14
06975339621971BubbleViewC50-CBR2026-08-14
06975339621179BubbleView®C50-C2024-07-10
06975339621186BubbleView®C50-CR2024-07-10
06975339621940BubbleView®C50-C2025-09-05
06975339621957BubbleViewC50-CR2025-09-05
06975339623418SeleneView®HO422026-07-03
06975339628406Single-Use Biopsy ForcepsBF-S-1.6×3802026-07-03
06975339628413Single-Use Alligator GrasperGF-S-1.6×3802026-07-03
06975339628420Single-use Endoscopic ScissorsPS-S-1.6×3802026-07-03
06975339628512Single-Use Biopsy ForcepsBF-F-1.8×6002026-07-03
06975339628529Single-Use Biopsy ForcepsBF-F-1.8×600-G2026-07-03
06975339628536Single-Use Biopsy ForcepsBF-F-1.8×600-O2026-07-03
06975339628550Single-Use Grasping ForcepsGF-F-1.8×6002026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140474WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140481WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140535WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140542WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28