SCANLAN® Suction System

Basic Information

• Brand Name: SCANLAN® Suction System
• Primary DI: 00846159035834
• Version / Model: 8008-995
• Catalog Number: 8008-995
• Company Name: SCANLAN INTERNATIONAL INC
• Labeler DUNS: 023055619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-23
• Public Version: 1
• Public Version Date: 2023-03-31
• Public Version Status: New
• Public Device Record Key: 9bc10887-88b3-4439-850d-225c360158a1

Device Description

Van Gompel™ Suction Non-Rotatable Tip, 11 French, 90 degree

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: 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: No
• 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
JOL	Catheter And Tip, Suction	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63649	General-purpose surgical suction system, vacuum	An assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846159035834	GS1

Customer Contacts

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