Xenon Rebreathing System 132-699

GUDID 10718175005078

KIT,XENON CONVENIENCE, FACE MASK WITH DIRECT DOSE ADMIN INCLUDES BACTERIA FILTER

BIODEX MEDICAL SYSTEMS, INC.

Xenon administration system, diagnostic nuclear medicine

• Primary Device ID: 10718175005078
• NIH Device Record Key: 0c134a77-47a3-4ed6-8e43-3af0daad1ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xenon Rebreathing System
• Version Model Number: 132-699
• Catalog Number: 132-699
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00718175005071 [Primary]
GS1	10718175005078 [Package]; Contains: 00718175005071; Package: BOX [25 Units]; In Commercial Distribution

FDA Product Code

• IYT: System, Rebreathing, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-24
• Device Publish Date: 2019-10-16

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