BullDog®

Basic Information

• Brand Name: BullDog®
• Primary DI: M7831203000
• Version / Model: 1203-00
• Catalog Number: 1203-00
• Company Name: DIVERSATEK HEALTHCARE, INC.
• Labeler DUNS: 030650113
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 9
• Public Version Date: 2024-07-25
• Public Version Status: Update
• Public Device Record Key: 7e2032f5-d7de-4338-8e1c-51770ed17afa

Device Description

Biopsy Valve - Non-Sterile, Olympus/Fujinon Compatible

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: Yes
• 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: No
• 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	Endoscope working-channel valve, single-use	A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7831203000	HIBCC
Package	M7831203001	HIBCC	Case	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]