FDA.reportPublic FDA data

NXSTAGE SYSTEM ONE - MOBILE STAND

Primary DI
M535NX01530
Brand
NXSTAGE SYSTEM ONE - MOBILE STAND
Company
NXSTAGE MEDICAL, INC.
Model
NX0153
Published
2024-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FOXStand, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M535NX01530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system, institutional/home-useAn assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
088013219
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M535CAR170B0NXSTAGE CARTRIDGE EXPRESSCAR-170-B2015-09-01
M535CAR171B0NXSTAGE CARTRIDGE EXPRESSCAR-171-B2015-09-01
M535CAR171C0NXSTAGE CARTRIDGE EXPRESSCAR-171-C2015-09-01
M535CAR1720NXSTAGE CARTRIDGE EXPRESSCAR-1722015-09-01
M535NX1272NxStage Dosing CalculatorNX12722015-09-01
M535NX06420NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KITNX06422015-09-01
M535NX13480NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KITNX13482015-09-01
M535NX13730NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KITNX13732015-09-01
M535FW300WW0EXPRESS FLUID WARMERFW-300-WW2015-09-01
M535NX100010B0VersiHDNX1000-10-B2021-12-08
00842289103245NxStage PureFlow SolutionRFP-207-C2026-06-22
00842289103252NxStage PureFlow SolutionRFP-204-C2026-06-22
00842289103269NxStage PureFlow SolutionRFP-209-C2026-06-22
00842289103764EXPRESS FLUID WARMERFW-300-WW2026-04-29
00842289103689System One Cycler BaseNX06422026-04-22
00842289103696Extended Cycler Base and Filter HolderNX13482026-04-22
00842289103702Fluid Detection SystemNX13732026-04-22
00842289103719VersiHDNX1000-10-B2026-04-22
00842289103894VersiHD with GuideMe SoftwareNX1000-10-E2025-09-23
00842289104044VersiHD with GuideMe SoftwareNX1000-16-H2025-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005549PryorPRYOR PRODUCTSFOX2026-10-16
00810050863667Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-10-14
00810050863674Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-10-14
00810050863650Triple Litter Stacking System (TLSS)LIFEPORT, LLCFOX2026-10-12
00810050863643Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-10-09
00761887005525CorCytePRYOR PRODUCTSFOX2026-10-06
00761887005501CorCytePRYOR PRODUCTSFOX2026-10-01
00761887005532PryorPRYOR PRODUCTSFOX2026-10-01
00761887005518CorCytePRYOR PRODUCTSFOX2026-09-28
00810050863629Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-22
00628678604124Micro Base ProTechnimount Medicale IncFOX2026-09-21
00628678604131PS5000 Clamp Block FQTechnimount Medicale IncFOX2026-09-21
00628678604148Bracket Pro Serie® 350 – MDTechnimount Medicale IncFOX2026-09-21
00628678604155Bracket Pro Serie® 360 - FQTechnimount Medicale IncFOX2026-09-21
00628678604162Bracket Pro Serie® 71Technimount Medicale IncFOX2026-09-21
00628678604179O2 Mount PS5000Technimount Medicale IncFOX2026-09-21
00628678604186Bracket Pro Serie® 26 – FQTechnimount Medicale IncFOX2026-09-21
00628678604193CARDIATEK®Technimount Medicale IncFOX2026-09-21
00810050863612Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-21
00628678604087ContinuuMed™ RIVTechnimount Medicale IncFOX2026-09-18
00628678604094ContinuuMed™ PVTTechnimount Medicale IncFOX2026-09-18
00628678604100Standard Surface BaseTechnimount Medicale IncFOX2026-09-18
00628678604117Universal BaseTechnimount Medicale IncFOX2026-09-18
00810050863544Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863551IV PoleLIFEPORT, LLCFOX2026-08-25
00810050863568Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863575Arch AssemblyLIFEPORT, LLCFOX2026-08-25
00810050863506Medical CabinetLIFEPORT, LLCFOX2026-08-03
00841027105695Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-06-26
00761887005488React HealthPRYOR PRODUCTSFOX2026-06-15