Bronchoscope Sheath Valve

Basic Information

• Brand Name: Bronchoscope Sheath Valve
• Primary DI: B634MBR0000200
• Version / Model: MBR-000020
• Catalog Number: MBR-000020
• Company Name: AURIS HEALTH, INC.
• Labeler DUNS: 015823456
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-08
• Public Version: 1
• Public Version Date: 2018-07-09
• Public Version Status: New
• Public Device Record Key: e90f3472-f75c-4d02-aaf0-c38afb0431be

Device Description

Bronchoscope Sheath Valve

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
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60760	Endoscope channel support kit	A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B634MBR0000200	HIBCC
Package	B634MBR0000201	HIBCC	Box	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K173760	000