CORE DYNAMICS

Basic Information

• Brand Name: CORE DYNAMICS
• Primary DI: 30653405074728
• Version / Model: CD3005NSB
• Catalog Number: CD3005NSB
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-12-08
• Public Version Status: Update
• Public Device Record Key: 983e317f-84d0-4a4c-a422-f19ec59d20b2
• Distribution End Date: 2020-12-08

Device Description

Insufflation Tubing with Filter

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: 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: 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
HES	INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES)	Obstetrics/Gynecology	884.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38559	Insufflation gas conditioning tubing set	A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30653405074728	GS1
Unit of Use	00653405074727	GS1

Customer Contacts

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