EVOTECH™

Basic Information

• Brand Name: EVOTECH™
• Primary DI: 10705037069316
• Version / Model: 0120801
• Catalog Number: 0120801
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Labeler DUNS: 947451626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-20
• Public Version: 2
• Public Version Date: 2025-12-15
• Public Version Status: Update
• Public Device Record Key: 9bb6791a-89fd-458d-8b09-07f05dbb7e26

Device Description

Channel Connector Tube, Orange

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FEB	Accessories, cleaning, for endoscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64640	Endoscope channel-opening adaptor	A small device intended to be manually attached to an endoscope channel/port (e.g., air/water channel, venting port), or an endoscope channel-opening button, to keep the channel open during sterilization/disinfection, typically to allow the luminal flow of a gas/solution or for pressure equalization between the endoscope interior and exterior (sterilizer chamber) to prevent damage. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10705037069316	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082392	000
K140977	000
K152189	000