FDA.reportPublic FDA data

PUREFLOW SL

Primary DI
M535NX20008EU0
Brand
PUREFLOW SL
Company
NXSTAGE MEDICAL, INC.
Model
NX2000-8-EU
Published
2015-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKRSubsystem, Proportioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKRSubsystem, ProportioningGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M535NX20008EU0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Combination water purification systemAn assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-866-697-8243info@nxstage.com

Regulatory Flags#

DUNS number
088013219
Device count
1
Serial number
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
M535NX01530NXSTAGE SYSTEM ONE - MOBILE STANDNX01532024-07-05
00842289103047NxStage PureFlow SolutionRFP-207-A2024-03-27
00842289103054NxStage PureFlow SolutionRFP-204-A2024-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M535NX200011D0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2023-12-04
M535NX200010D0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2023-12-04
M535NX200011A0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2023-06-21
M535NX20002A0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2016-11-17
M535NX20001CAN0PUREFLOW SL - CONTROL UNITNXSTAGE MEDICAL, INC.FKR2016-07-21
M535NX20002CAN0PUREFLOW SL - CHASSISNXSTAGE MEDICAL, INC.FKR2016-07-21
M535SAK301A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK302A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK303A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK304A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK305A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK306A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK307A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK401A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK402A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK403A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK404A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK405A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK406A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535SAK407A0Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-10-30
M535NX2000100PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-02
M535SAK4020Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-09-02
M535SAK4030Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-09-02
M535SAK4070Dialysate Sack (SAK) with ConcentrateNXSTAGE MEDICAL, INC.FKR2015-09-02
M535NX200010PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX2000110PUREFLOW SL KITNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX200011EU0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX20001A0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX200020PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01
M535NX20002EU0PUREFLOW SLNXSTAGE MEDICAL, INC.FKR2015-09-01