FDA.reportPublic FDA data

Xenon Rebreathing System

Primary DI
00718175005040
Brand
Xenon Rebreathing System
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
132-690
Catalog number
132-690
Device description
KIT, XENON CONVENIENCE, FACE MASK W INJECTION PORT INCLUDES BATERIA FILTER
Published
2019-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IYTSystem, Rebreathing, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYTSystem, Rebreathing, RadionuclideRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10718175005047PackageGS125Not in Commercial Distribution
00718175005040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071817500504710718175005047
00718175005040007181750050407181750050400718175005040

GMDN Terms#

Term, Definition table
TermDefinition
Xenon administration system, diagnostic nuclear medicineAn assembly of devices which is considered to be a component of a nuclear medicine (NM) imaging system [e.g., a gamma camera or a single photon emission computed tomography (SPECT)] and is used as a rebreathing device to deliver gas to the patient and contain the exhaled radioactive xenon gas used during real-time imaging studies of lung function, blood flow or other physical or physiological parameters. It is designed to minimize release of radioactive gas into the working environment during imaging procedures.

Regulatory Flags#

DUNS number
043833813
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175003381SHARPS CONTAINER SHIELD 039-350039-3502019-05-31
00718175003657Neck Phantom 043-365043-3652018-02-15
00718175005002Xenon Rebreathing System 132-680132-6802019-09-30
00718175005019Xenon Rebreathing System 132-681132-6812019-10-16
00718175005057Xenon Rebreathing System 132-691132-6912019-10-16
00718175005064Xenon Rebreathing System 132-692132-6922019-10-16
00718175005071Xenon Rebreathing System 132-699132-6992019-10-16
00718175005088Xenon Rebreathing System 132-770132-7702019-10-16
00718175005101Xenon Rebreathing System 132-774132-7742019-10-17
00718175005125Xenon Rebreathing System 132-784132-7842019-10-16
00718175005132Xenon Rebreathing System 132-793132-7932019-10-16
00718175005149Xenon Rebreathing System 132-771132-7712019-10-16
00718175005156VENTI-SCAN IV177-075177-0752019-12-13
00718175005163AIR CUSHIONED FACE MASK132-685132-6852019-12-13
00718175005170AIR CUSHIONED FACE MASK132-695132-6952019-12-13
00718175005187AIR CUSHIONED FACE MASK132-698132-6982019-12-13
00718175005200BACTERIAL FILTER132-750132-7502019-12-13
00718175005248XENON CONVENIENCE KITS 134-772134-7722019-12-13
00718175002902LEAD LINED 244-157244-1572020-06-17
00718175087640BETA, Syringe Shield 007-958007-9582021-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850022357848Xenon MasterMedi/Nuclear Corporation, Inc.IYT2024-09-10
00850022357855Xenon MasterMedi/Nuclear Corporation, Inc.IYT2024-09-10
00850022357787Insta/Vent, Insta/Vent Plus, MedicatorMedi/Nuclear Corporation, Inc.IYT2023-12-07
00850022357770Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2023-12-07
10850022357784Insta/Vent, Insta/Vent Plus, MedicatorMedi/Nuclear Corporation, Inc.IYT2023-12-07
00850022357794Xenon MasterMedi/Nuclear Corporation, Inc.IYT2023-12-07
00850022357800Xenon MasterMedi/Nuclear Corporation, Inc.IYT2023-12-07
00879942070125AeroTech I Convenience Kit, Small ParticleMirion Technologies (capintec), Inc.IYT2022-08-09
00879942070101AeroTech I Shield Mirion Technologies (capintec), Inc.IYT2022-08-08
00879942070118AeroTech I Convenience Kit, StandardMirion Technologies (capintec), Inc.IYT2022-08-08
00879942070132AeroTech I Convenience Kit, Venti Pak Mirion Technologies (capintec), Inc.IYT2022-08-08
00879942070149Venti-Scan IV ShieldMirion Technologies (capintec), Inc.IYT2022-08-08
00879942070156Venti-Scan IV Convenience Kit, 24 inch tubingMirion Technologies (capintec), Inc.IYT2022-08-08
00879942070163Venti-Scan IV Convenience Kit, Venti PakMirion Technologies (capintec), Inc.IYT2022-08-08
00879942070170Venti-Scan IV Convenience Kit, 12 inch tubingMirion Technologies (capintec), Inc.IYT2022-08-08
00850022357602Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357664Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357596Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357619Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357626Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357640Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357671Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357688Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2022-04-18
00850022357114Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357121Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357138Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357169N/AMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357183Insta/Vent - Lung Ventilation AccessoriesMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357237Xenon MasterMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357244Xenon MasterMedi/Nuclear Corporation, Inc.IYT2020-11-09