8000 Series Reusable Channel Cleaning Brush

Basic Information

• Brand Name: 8000 Series Reusable Channel Cleaning Brush
• Primary DI: M45387010
• Version / Model: 8701
• Catalog Number: 8701
• Company Name: Primed Instruments Inc
• Labeler DUNS: 254491293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-20
• Public Version: 1
• Public Version Date: 2018-12-21
• Public Version Status: New
• Public Device Record Key: 7f22820c-ecea-41dd-a939-2bb808ea8574

Device Description

Reusable Channel Cleaning Micro Brush. HIBC/UPN: M45387010

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35979	Endoscope cleaning brush, reusable	A device used to remove dirt or debris from the working channel(s) and irregular surface of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube or metal coil with plastic bristles. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M45387010	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Working Length: 95cm
Device Size Text, specify			Brush Diameter: 2.3mm
Device Size Text, specify			Minimum Channel Size: 1.0mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Reusable Cleaning Brushes should be stored in a sterile package at room temperature in a dry clean area away from direct sunlight. Each device is individually packaged.