Xenon Rebreathing System 060-137

GUDID 00718175001370

Disposable Xenon Rebreathing System

BIODEX MEDICAL SYSTEMS, INC.

Xenon administration system, diagnostic nuclear medicine

• Primary Device ID: 00718175001370
• NIH Device Record Key: 528346e5-8bd1-49a5-a221-d60d50f0ae83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xenon Rebreathing System
• Version Model Number: 060-137
• Catalog Number: 060-137
• 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	00718175001370 [Primary]
GS1	10718175001384 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	20718175001398 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	30718175001401 [Package]; Package: Box [15 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-18

On-Brand Devices [Xenon Rebreathing System]

• 00718175001370: Disposable Xenon Rebreathing System
• 00718175001332: Disposable Xenon-133 Rebreathing System
• 10718175005009: KIT, XENON CONVENIENCE, FACE MASK & BACTERIA FILTER
• 10718175005146: KIT, XENON CONVENIENCE, MOUTHPIECE AND ADMINISTRATION ADAPTER INCLUDES BACTERIA FILTER,NOSE CLIP
• 10718175005139: KIT, XENON CONVENIENCE, FACE MASK WITH DIRECT DOSE INCLUDES BACTERIA FILTER, ULTRA-FLEX TUBING,
• 10718175005122: KIT, XENON CONVENIENCE, FACE MASK WITH INJECTION PORT INCLUDES BACTERIA FILTER, ULTRA-FLEX TUBIN
• 00718175005118: KIT, XENON CONVENIENCE, FACE MASK, INCUDES BACTERIA FILTER ULTRA-FLEX TUBING, DRIERITE AND SODA
• 10718175005085: KIT, XENON CONVENIECE, MOUTHPIECE INCLUDES BACTERIA FILTER AND NOSE CLIP
• 10718175005078: KIT,XENON CONVENIENCE, FACE MASK WITH DIRECT DOSE ADMIN INCLUDES BACTERIA FILTER
• 10718175005061: KIT, XENON CONVENIENCE, FACE MASK WITH DIRECT DOSE ADMIN INCLUDES BACTERIA FILETER AND ULTRA-FLE
• 10718175005054: KIT, XENON CONVENIENCE, FACE MASK WITH INJECTION PORT, INCLUDES BACTERIA FILTER AND ULTRA-FLEX T
• 10718175005047: KIT, XENON CONVENIENCE, FACE MASK W INJECTION PORT INCLUDES BATERIA FILTER
• 00718175005026: KIT, XENON CNVC, FACE MASK, WITH LUER-LOCK INJECTION PORT
• 10718175005016: KIT, XENON CNVC, FACE MASK, BATERIA FILTER AND ULTRA-FLEX TUBING
• 10718175005108: KIT, XENON CONVENIENCE, MOUTHPIECE AND ADMINISTRATION ADAPTER INCLUDES BACTERIA FILTER, NOSE CLI