Xenon Master

GUDID 00857863007390

Xenon/Master Patient Delivery System. (For Xenon Gas Delivery). Mobile Cabinet type constructed of wood and almond color formica with leaded areas for Xenon Delivery. Includes one charcoal activated trap and has extra space for one additional activated trap (optional) for high use facilities, swivel casters with front brakes. Xenon accessory samples included.

Medi/Nuclear Corporation, Inc.

Xenon administration system, diagnostic x-ray/CT

• Primary Device ID: 00857863007390
• NIH Device Record Key: 08f0a865-788a-4fba-89fe-b368461e852a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xenon Master
• Version Model Number: XE-102
• Company DUNS: 079628327
• Company Name: Medi/Nuclear Corporation, Inc.
• 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: true
• 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: 800-321-5981
• Email: cs@medinuclear.com

Device Dimensions

• Width: 18 Inch
• Width: 18 Inch
• Width: 18 Inch
• Width: 18 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857863007390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810819

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-09

On-Brand Devices [Xenon Master]

• 00857863007390: Xenon/Master Patient Delivery System. (For Xenon Gas Delivery). Mobile Cabinet type constructed
• 00850022357800: C02 Absorbing Granule Cartridge, Disposable, (Soda Lime)
• 00850022357794: Moisture Absorbing Granule Cartridge, Disposable, (Drierite)
• 00850022357855: Xenon Administration Set: 1 EA MN0312: Air Cushion Face Mask with Direct Dose Luer Lock, Ultra-
• 00850022357848: Xenon Administration Set: 1 EA MN0309: Face Mask, Air-Cushioned, Adult Size 5, with Injection P
• 00850022357831: Soda Lime, Plastic Container, 4 Lb for Xenon Administration System
• 00850022357824: Drierite, Indicating Blue/White Blend, Plastic Jar, 4 Lb. for Xenon Administration System
• 00850022357817: Drierite, Indicating Blue/White Blend, Plastic Jar, 1 Lb. for Xenon Administration System