NA

Basic Information

• Brand Name: NA
• Primary DI: 00724995180430
• Version / Model: 710602
• Catalog Number: 710602
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-02
• Public Version: 3
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 394409ee-c8c2-44ad-8ba4-06bf62703329

Device Description

The Two tank shuttle valve system is for use with an insufflator to attach two medical grade CO2 cylinders simultaneously. This reduces the likelihood of running out of CO2 during a procedure.

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: 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
FCX	INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE	Gastroenterology, Urology	876.1500	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
Previous	00816765013151	GS1
Primary	00724995180430	GS1

Customer Contacts

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