FDA.reportPublic FDA data

Digital Video Monitor

Primary DI
06972197480696
Brand
Digital Video Monitor
Company
Hunan Vathin Medical Instrument Co., Ltd
Model
DVM-B2
Published
2023-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223836000Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.2023-05-15EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972197480693PackageGS11In Commercial Distribution
06972197480696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697219748069316972197480693
06972197480696069721974806966972197480696

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image display unitAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a flexible video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554484862
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972197483420Single-use Ureteral Access SheathUA-S18022025-08-08
06972197483437Single-use Ureteral Access SheathUA-S18032025-08-08
06972197483444Single-use Ureteral Access SheathUA-S1A022025-08-08
06972197483451Single-use Ureteral Access SheathUA-S1A032025-08-08
06972197483468Single-use Ureteral Access SheathUA-S1B022025-08-08
06972197483475Single-use Ureteral Access SheathUA-S1B032025-08-08
06972197483482Single-use Ureteral Access SheathUA-S1C022025-08-08
06972197483499Single-use Ureteral Access SheathUA-S1C032025-08-08
06972197483505Single-use Ureteral Access SheathUA-S1D022025-08-08
06972197483512Single-use Ureteral Access SheathUA-S1D032025-08-08
06972197482225Single-use Ureteral Access SheathUA-S18002024-11-04
06972197482232Single-use Ureteral Access SheathUA-S18012024-11-04
06972197482249Single-use Ureteral Access SheathUA-S1A002024-11-04
06972197482256Single-use Ureteral Access SheathUA-S1A012024-11-04
06972197482263Single-use Ureteral Access SheathUA-S1B002024-11-04
06972197482270Single-use Ureteral Access SheathUA-S1B012024-11-04
06972197482287Single-use Ureteral Access SheathUA-S1C002024-11-04
06972197482294Single-use Ureteral Access SheathUA-S1C012024-11-04
06972197482300Single-use Ureteral Access SheathUA-S1D002024-11-04
06972197482317Single-use Ureteral Access SheathUA-S1D012024-11-04

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Primary DI, Brand, Company table
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