Full HD Endoscopic Image Processor

GUDID 06971381252545

This product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power cable and video cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional. This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Endoscopic video image processing unit

• Primary Device ID: 06971381252545
• NIH Device Record Key: 69dfd670-ca8f-48a4-927a-6eaff2f087c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Full HD Endoscopic Image Processor
• Version Model Number: HDVS-S200B
• Company DUNS: 544519831
• Company Name: SCIVITA MEDICAL TECHNOLOGY 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971381252545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240289

FDA Product Code

• EOQ: Bronchoscope (Flexible Or 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: 2024-12-13
• Device Publish Date: 2024-12-05

On-Brand Devices [Full HD Endoscopic Image Processor]

• 06971381252569: This product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power c
• 06971381252552: This product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power c
• 06971381252545: This product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power c
• 06971381252538: This product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power c