FDA.reportPublic FDA data

Xenon Rebreathing System

Primary DI
00718175005088
Brand
Xenon Rebreathing System
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
132-770
Catalog number
132-770
Device description
KIT, XENON CONVENIECE, MOUTHPIECE INCLUDES BACTERIA FILTER AND NOSE CLIP
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
10718175005085PackageGS125Not in Commercial Distribution
00718175005088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071817500508510718175005085
00718175005088007181750050887181750050880718175005088

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
00718175005040Xenon Rebreathing System 132-690132-6902019-10-16
00718175005057Xenon Rebreathing System 132-691132-6912019-10-16
00718175005064Xenon Rebreathing System 132-692132-6922019-10-16
00718175005071Xenon Rebreathing System 132-699132-6992019-10-16
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