Image Processor

Primary DI
06970462546146
Brand
Image Processor
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
VLM-03
Published
2023-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)
EOQBronchoscope (Flexible Or Rigid)
FAJCystoscope And Accessories, Flexible/Rigid
FBNCholedochoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FBNCholedochoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222910000
K231118000
K231497000
K232435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222910000Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-04-11EOQ
K231118000Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-11-13FAJ
K231497000Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-03-06FBN
K232435000Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-04-26EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970462546146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970462546146069704625461466970462546146

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
403655303
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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06979988682017Single-Use UreterorenoscopeHU30M-V2026-07-25
06979988682024Single-Use UreterorenoscopeHU30SC-V2026-07-25
06979988682031Single-Use UreterorenoscopeHU30SC2026-07-25
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06970462547358HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/082026-07-11
06970462547365HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/112026-07-11
06970462547372HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/082026-07-11
06970462547389HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/112026-07-11
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06970462546771Single-use Ureteral Access SheathY-10-502025-07-23
06970462546788Single-use Ureteral Access SheathY-11-402025-07-23
06970462546795Single-use Ureteral Access SheathY-11-502025-07-23
06970462546801Single-use Ureteral Access SheathY-12-402025-07-23
06970462546818Single-use Ureteral Access SheathY-12-502025-07-23
06970462547457Single-use Ureteral Access SheathY-08-362026-02-10
06970462547464Single-use Ureteral Access SheathY-08-402026-02-10
06970462547471Single-use Ureteral Access SheathY-08-452026-02-10

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