Eview

GUDID 06971176280043

This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.

Zhuhai Pusen Medical Technology Co, Ltd

Endoscopic video image processing unit

• Primary Device ID: 06971176280043
• NIH Device Record Key: 6538898b-373d-448c-8335-dc6baf354d97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eview
• Version Model Number: PV210
• Company DUNS: 544427443
• Company Name: Zhuhai Pusen Medical Technology Co, Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971176280043 [Primary]
GS1	16971176280040 [Package]; Package: box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190648

FDA Product Code

• FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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: 2019-04-17
• Device Publish Date: 2019-04-09

On-Brand Devices [Eview]

• 16971176280002: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forc
• 06971176280043: This equipment has been designed to be used to process signals from an endoscope and convert it
• 06971176280135: This equipment has been designed to be used to process signals from an endoscope and convert it
• 06971176280241: This instrument has been designed to be used to process signals from a video endoscope and conve