CO2 Hose and Yoke Shuttle Valve System

Basic Information

• Brand Name: CO2 Hose and Yoke Shuttle Valve System
• Primary DI: 00817183020202
• Version / Model: 7-510-50
• Company Name: NORTHGATE TECHNOLOGIES INC.
• Labeler DUNS: 627969264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 4
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 8f8f54d3-a01c-4586-a9ca-e095b73eced2

Device Description

CO2 Hose and Yoke Shuttle Valve System is for use with Laparoscopic insufflators for hook up to two CO2 tanks.

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: MR Unsafe
• 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
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	884.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14239	High-pressure medical gas hose	A length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials (e.g., plastic, rubber, or nylon), and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817183020202	GS1

Premarket Submissions

Submission Number	Supplement Number
K022052	000