Image Processor

GUDID 06970462546122

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Endoscopic video image processing unit
Primary Device ID06970462546122
NIH Device Record Key00bd18ef-4db1-4a80-be49-1fe7bbe9779d
Commercial Distribution StatusIn Commercial Distribution
Brand NameImage Processor
Version Model NumberVLM-02
Company DUNS403655303
Company NameShenzhen HugeMed Medical Technical Development Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970462546122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)
EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-22
Device Publish Date2023-09-14

On-Brand Devices [Image Processor]

06970462546146VLM-03
06970462546122VLM-02
16970462546297HUV-01
16970462546204HUV-02
06970462546191MS-8

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