9000 Series Disposable Channel Cleaning Brush

Basic Information

• Brand Name: 9000 Series Disposable Channel Cleaning Brush
• Primary DI: 00666416120147
• Version / Model: 9192
• Catalog Number: 9192
• Company Name: Primed Instruments Inc
• Labeler DUNS: 254491293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2017-10-23
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: c879cf9f-bfb3-409f-ad70-ca50caacf332

Device Description

Disposable Triple Headed Push & Pull Channel Cleaning Brush. HIBC/UPN: M45391922

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: 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: No

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
38835	Surgical instrument/endoscope cleaning utensil, single-use	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00666416120147	GS1
Unit of Use	00666416120451	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: 3-6.3mm
Device Size Text, specify			Overall Length: 240cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store cleaning brushes in original packaging at room temperature in a dry clean location away from direct sunlight. Each dispenser box contains 25 cleaning brush kits.