Xenotron N046A0

GUDID 00369945000002

Xenon (Xe 133) Gas Dispenser

CURIUM US LLC

Xenon administration system, diagnostic x-ray/CT

• Primary Device ID: 00369945000002
• NIH Device Record Key: b22b3e71-a2e7-4e0d-9377-7fb0a2ac571e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xenotron
• Version Model Number: 1
• Catalog Number: N046A0
• Company DUNS: 079875617
• Company Name: CURIUM US LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)789-2211
• Email: pvnorthamerica@curiumpharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00369945000002 [Primary]

FDA Product Code

• IYT: System, rebreathing, radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-10
• Device Publish Date: 2016-09-24

Devices Manufactured by CURIUM US LLC

• 00369945000019 - Ultravent: 2023-09-01 Ultravent Radioaerosol Delivery System
• 00369945000002 - Xenotron: 2020-02-10Xenon (Xe 133) Gas Dispenser
• 00369945000002 - Xenotron: 2020-02-10 Xenon (Xe 133) Gas Dispenser