AccessGUDID - DEVICE: Disposable Biopsy Valve (06970401812387)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Biopsy Valve
Version or Model: MDBV1A0000A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000522
Company Name: Zhejiang Chuangxiang Medical Technology Co., LTD.

Primary DI Number: 06970401812387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544434963 *Terms of Use

Device Description: ClearGuard Disposable Biopsy Valve for Olympus and Fujinon GI Endoscopes

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
60757	Endoscopic biopsy valve, sterile	A sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OCX	Endoscopic Irrigation/Suction System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173758	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: da470c43-649c-47d4-b57d-dbe27c46f080
Public Version Date: July 18, 2022
Public Version Number: 3
DI Record Publish Date: June 18, 2019