Disposable Biopsy Valve

Basic Information

• Brand Name: Disposable Biopsy Valve
• Primary DI: 06970401814343
• Version / Model: MD-A-BV01
• Company Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
• Labeler DUNS: 544434963
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-24
• Public Version: 4
• Public Version Date: 2022-07-18
• Public Version Status: Update
• Public Device Record Key: 42c2a833-2c0c-4536-b594-03f9e74c0c87

Device Description

product color: purple

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62145	Endoscopic biopsy valve, single-use	A 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 features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26970401814361	GS1	Case	5	In Commercial Distribution
Package	16970401814357	GS1	Box	100	In Commercial Distribution
Primary	06970401814343	GS1

Premarket Submissions

Submission Number	Supplement Number
K173758	000