Xenotron

Basic Information

• Brand Name: Xenotron
• Primary DI: 00369945000002
• Version / Model: 1
• Catalog Number: N046A0
• Company Name: CURIUM US LLC
• Labeler DUNS: 079875617
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-02-10
• Public Version Status: Update
• Public Device Record Key: b22b3e71-a2e7-4e0d-9377-7fb0a2ac571e

Device Description

Xenon (Xe 133) Gas Dispenser

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: Yes
• Has Lot/Batch Number: No
• 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
IYT	System, rebreathing, radionuclide	Radiology	892.1390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40907	Xenon administration system, diagnostic x-ray/CT	An assembly of devices which is a component of an x-ray/CT (computed tomography) system used in diagnostic x-ray applications for the delivery (by inhalation or injection) of xenon gas during real-time imaging studies of blood flow or other physical or physiological parameters. It can be a simple canister system with associated tubing, mask or mouthpiece, or be composed of an electrically or software-controlled operator's console that includes, e.g., software, injector system, physiological gating devices, gas canister holder(s), gas mixers, tubing sets, gas traps, filters, alarms, mask or mouthpieces.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00369945000002	GS1

Customer Contacts

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