Image Processor

GUDID 16970462546297

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Endoscopic video image processing unit

• Primary Device ID: 16970462546297
• NIH Device Record Key: 5296d885-f1b3-40ed-990f-070542618c01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image Processor
• Version Model Number: HUV-01
• Company DUNS: 403655303
• Company Name: Shenzhen HugeMed Medical Technical Development Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970462546290 [Primary]
GS1	16970462546297 [Package]; Contains: 06970462546290; Package: CASE [1 Units]; Discontinued: 2024-06-11; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231118

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-19
• Device Publish Date: 2024-06-11

On-Brand Devices [Image Processor]

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