Xenon Rebreathing System

Basic Information

• Brand Name: Xenon Rebreathing System
• Primary DI: 00718175005026
• Version / Model: 132-684
• Catalog Number: 132-684
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Labeler DUNS: 043833813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-16
• Public Version: 2
• Public Version Date: 2020-03-02
• Public Version Status: Update
• Public Device Record Key: 98e481b1-d998-4ca2-8c26-e8f8a273dab2

Device Description

KIT, XENON CNVC, FACE MASK, WITH LUER-LOCK INJECTION PORT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
IYT	System, Rebreathing, Radionuclide	Radiology	892.1390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40908	Xenon administration system, diagnostic nuclear medicine	An assembly of devices which is considered to be a component of a nuclear medicine (NM) imaging system [e.g., a gamma camera or a single photon emission computed tomography (SPECT)] and is used as a rebreathing device to deliver gas to the patient and contain the exhaled radioactive xenon gas used during real-time imaging studies of lung function, blood flow or other physical or physiological parameters. It is designed to minimize release of radioactive gas into the working environment during imaging procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00718175005026	GS1
Package	10718175005023	GS1	Box	25	In Commercial Distribution