FDA.reportPublic FDA data

ViewHub

Primary DI
26975339626680
Brand
ViewHub
Company
MacroLux Medical Technology Co., Ltd.
Model
S13
Device description
Video Processor
Published
2025-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26975339626680PackageGS11In Commercial Distribution
06975339626686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697533962668026975339626680
06975339626686069753396266866975339626686

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
723490133
Device count
1
DM exempt
false
Premarket exempt
false
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
06975339620318CoralView®U10-B2024-03-12
06975339620325CoralView®U10-BR2024-03-12
06975339620332CoralView®U202024-03-28
06975339620349CoralView®U20-B2024-03-28
06975339620356CoralView®U20-BR2024-03-28
06975339621179BubbleView®C50-C2024-07-10
06975339621186BubbleView®C50-CR2024-07-10
06975339621193BubbleView®C50-CB2024-07-10
06975339621209BubbleView®C50-CBR2024-07-10
06975339623173SeleneView®HC29-G2024-08-23
06975339623180SeleneView®HC352024-08-23
06975339623197SeleneView®HC35-G2024-08-23
06975339623203SeleneView®HO352024-08-23
06975339623210SeleneView®HO35-G2024-08-23
06975339623227SeleneView®HO422024-08-23
06975339623234SeleneView®HO42-G2024-08-23
06975339627560CoralWellNS-0835B2025-08-10
06975339627577CoralWellNS-0840B2025-08-10
06975339627584CoralWellNS-0845B2025-08-10
06975339627591CoralWellNS-0855B2025-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.EOQ2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.EOQ2026-05-27
04719872715108MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715115MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715122MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
00856571007265EasyPath RF Introducer SheathBRONCUS MEDICAL INC.EOQ2026-04-23
04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00850048825086Galaxy System (Cart) - RefurbishedNoah Medical CorporationEOQ2025-10-25
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811510Monarch™ Laptop P17 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
10810068811527Monarch™ Laptop P16 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
10810068810834Bronchoscope Fluidics TubingAuris Health, Inc.EOQ2024-05-05
10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05
10810068810872Bronchoscope Sheath ValveAuris Health, Inc.EOQ2024-05-05
10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
10810068810797Monarch™ Laptop P17/P73 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
04048551446690N/AKarl Storz GmbH & Co. KGEOQ2023-08-14
10818634025118AmbuBosma EnterprisesEOQ2023-05-01
10818634025132AmbuBosma EnterprisesEOQ2023-05-01
10818634025156AmbuBosma EnterprisesEOQ2023-05-01
10818634025163AmbuBosma EnterprisesEOQ2023-05-01
00850023925206WiScope®Otu Medical Inc.EOQ2023-04-30