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
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
00842289104051VersiHD with GuideMe SoftwareNX1000-10-H2025-09-23
M535NX100010E0VersiHD with GuideMe softwareNX1000-10-E2023-08-21
M535RFP205WW0NxStage PureFlow SolutionRFP-205-WW2015-09-01
M535RFP205WW5NxStage PureFlow SolutionRFP-205-WW2015-09-01
M535NX100010G0VersiHD with GuideMe softwareNX1000-10-G2024-01-25
M535NX100010F0VersiHD with GuideMe softwareNX1000-10-F2023-08-21
M535NX100016F0VersiHD with GuideMe softwareNX1000-16-F2023-08-21
M535NX1272NxStage Dosing CalculatorNX12722015-09-01
00842289103870NXSTAGE CARTRIDGE EXPRESSCAR-170-E2024-07-24
00842289103887NXSTAGE CARTRIDGE EXPRESSCAR-172-E2024-07-24
00842289103047NxStage PureFlow SolutionRFP-207-A2024-03-27
00842289103054NxStage PureFlow SolutionRFP-204-A2024-03-27
00842289103061NxStage PureFlow SolutionRFP-209-A2024-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005464PryorPRYOR PRODUCTSFOX2026-05-26
00810050863469AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863414Pole MountLIFEPORT, LLCFOX2026-04-28
00810050863421Pole MountLIFEPORT, LLCFOX2026-04-28
B458205997000HVP CartThe Wells Johnson CompanyFOX2026-04-20
B458205998000Wells Johnson Hymen CartThe Wells Johnson CompanyFOX2026-04-20
00810050863407Load RampLIFEPORT, LLCFOX2026-04-17
09420012405890Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012409690Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012416728Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
00810050863391Medical CabinetLIFEPORT, LLCFOX2026-04-07
04260217220158chapot® table System Siemens Artis zee / Q / Q.zenAmtrion GmbHFOX2026-03-30
04260217220196chapot® table System Siemens ARTIS pheno / iconoAmtrion GmbHFOX2026-03-30
09420012405999Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26
09420012406019Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26
09420012405913Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-23
09420012425805Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
09420012426871Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
09420012433961Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
04061162024637CIM med GmbHCIM med GmbHFOX2026-03-18
04061162042907CIM med GmbHCIM med GmbHFOX2026-03-18
04061162086086CIM med GmbHCIM med GmbHFOX2026-03-18