Xenon Rebreathing System 132-774

GUDID 10718175005108

KIT, XENON CONVENIENCE, MOUTHPIECE AND ADMINISTRATION ADAPTER INCLUDES BACTERIA FILTER, NOSE CLIP AND ULTRA-FLEX TUBING

BIODEX MEDICAL SYSTEMS, INC.

Xenon administration system, diagnostic nuclear medicine
Primary Device ID10718175005108
NIH Device Record Key491e6a53-22c5-48d6-b8ff-3ce89f93f5e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameXenon Rebreathing System
Version Model Number132-774
Catalog Number132-774
Company DUNS043833813
Company NameBIODEX MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100718175005101 [Primary]
GS110718175005108 [Package]
Contains: 00718175005101
Package: BOX [25 Units]
In Commercial Distribution

FDA Product Code

IYTSystem, Rebreathing, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-25
Device Publish Date2019-10-17

On-Brand Devices [Xenon Rebreathing System ]

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

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