FDA.report

Pulmonex

Primary DI
00718175005033
Brand
Pulmonex
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
132-503
Catalog number
132-503
Device description
Pulmonex Xenon System
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IYTSystem, Rebreathing, Radionuclide

Product Code Classifications

CodeDeviceSpecialtyClass
IYTSystem, Rebreathing, RadionuclideRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00718175005033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175005033007181750050337181750050330718175005033

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
043833813
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00718175002902LEAD LINED 244-157244-1572020-06-17
00718175002407Biostep 2, 100-240 VAC950-2402024-05-06
00718175006009Reactive Step Trainer 115V950-6002024-05-06
00718175001462Biodex950-146950-1462023-08-02
00718175001486Biodex950-148950-1482023-08-02
00718175005606Sit2Stand950-560950-5602023-07-31
00718175004302VibroTactile950-4302023-07-19
00718175087640BETA, Syringe Shield 007-958007-9582021-01-07
00718175087626VENTI-SCAN IV177-090177-0902020-10-15
00718175087633Aerotech I Radioaerosol Administration System 177-095177-0952020-10-15
00718175002780LEAD LINED 244-136244-1362020-08-26
00718175087619LEAD LINED 244-156244-1562020-08-13
00718175002292LEAD LINED 244-146244-1462020-06-24
00718175004050MJS System 3 Upgrade850-820850-8202017-12-18
00718175002766LEAD LINED 244-206244-2062020-04-13
00718175004708SHIELDED STORAGE CONTAINER050-200050-2002020-04-13
00718175004753SHIELDED STORAGE CONTAINER050-205050-2052020-04-13
00718175004784SHIELDED STORAGE CONTAINER050-250050-2502020-04-13
00718175008478VIAL SHIELD053-610053-6102020-04-13
00718175008614VIAL SHIELD053-611053-6112020-04-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850022357848Xenon MasterMedi/Nuclear Corporation, Inc.IYT2024-09-10
00850022357855Xenon MasterMedi/Nuclear Corporation, Inc.IYT2024-09-10
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 ParticleCAPINTEC, INC.IYT2022-08-09
00879942070101AeroTech I Shield CAPINTEC, INC.IYT2022-08-08
00879942070118AeroTech I Convenience Kit, StandardCAPINTEC, INC.IYT2022-08-08
00879942070132AeroTech I Convenience Kit, Venti Pak CAPINTEC, INC.IYT2022-08-08
00879942070149Venti-Scan IV ShieldCAPINTEC, INC.IYT2022-08-08
00879942070156Venti-Scan IV Convenience Kit, 24 inch tubingCAPINTEC, INC.IYT2022-08-08
00879942070163Venti-Scan IV Convenience Kit, Venti PakCAPINTEC, INC.IYT2022-08-08
00879942070170Venti-Scan IV Convenience Kit, 12 inch tubingCAPINTEC, INC.IYT2022-08-08
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
00850022357176N/AMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357541Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357558Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357572Insta/Vent - Lung Ventilation AccessoriesMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357190Insta/Vent - Lung Ventilation AccessoriesMedi/Nuclear Corporation, Inc.IYT2020-11-09
00850022357565Xenon Master Administration SetMedi/Nuclear Corporation, Inc.IYT2020-11-09
00718175087626VENTI-SCAN IVBIODEX MEDICAL SYSTEMS, INC.IYT2020-10-15
30718175005157VENTI-SCAN IVBIODEX MEDICAL SYSTEMS, INC.IYT2019-12-13
10718175005160AIR CUSHIONED FACE MASKBIODEX MEDICAL SYSTEMS, INC.IYT2019-12-13
10718175005177AIR CUSHIONED FACE MASKBIODEX MEDICAL SYSTEMS, INC.IYT2019-12-13