CeroFrict

Basic Information

• Brand Name: CeroFrict
• Primary DI: 04897129990000
• Version / Model: SML001-PT12
• Company Name: SML Med-Tech Solutions Limited
• Labeler DUNS: 687239367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-05
• Public Version: 1
• Public Version Date: 2023-05-15
• Public Version Status: New
• Public Device Record Key: 2bc74e4f-7685-44f2-aaba-eb9f120a8208

Device Description

Air Water Channel Cleaning Adapter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66650	Endoscope flushing/rinsing sink system	An electrically-powered assembly of devices intended to be used to flush and rinse endoscopes for pre-cleaning. It is intended to be connected to hot and cold water supplies and includes a sink with conventional style taps to facilitate pre-cleaning the external portion of the endoscopes, and a series of fluid lines for flushing each endoscope channel.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14897129990007	GS1		150	In Commercial Distribution
Primary	04897129990000	GS1
Package	24897129990004	GS1		4	In Commercial Distribution