8000 Series Reusable Channel Cleaning Brush

Basic Information

• Brand Name: 8000 Series Reusable Channel Cleaning Brush
• Primary DI: 00666416110087
• Version / Model: 8195
• Catalog Number: 8195
• Company Name: Primed Instruments Inc
• Labeler DUNS: 254491293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4e617cd7-bf7e-4d50-bd55-d14226aa9373

Device Description

Reusable Tapered Cleaning Brush. HIBC/UPN: M45381950

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	00666416110087	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Minimum Channel Size: 2.0mm
Device Size Text, specify			Brush Diameter: 3.0-6.0mm
Device Size Text, specify			Working Length: 250cm

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.