AccessGUDID - DEVICE: Eview (06971176280043)

GUDID

Device Identifier (DI) Information

Brand Name: Eview
Version or Model: PV210
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zhuhai Pusen Medical Technology Co, Ltd

Primary DI Number: 06971176280043
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544427443 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
18034	Endoscopic video image processing unit	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190648	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6538898b-373d-448c-8335-dc6baf354d97
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: April 09, 2019