FDA.reportPublic FDA data

NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT

Primary DI
M535NX13480
Brand
NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
Company
NXSTAGE MEDICAL, INC.
Model
NX1348
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOCAccessories, Blood Circuit, Hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M535NX13480PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system blood leak detectorAn electrically-powered integral unit of a haemodialysis system that detects blood leaks in the effluent side of the dialysate within the system and sounds an alarm if there is blood detected on this non-blood side.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
088013219
Device count
1
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
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
00842289103689System One Cycler BaseNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103696Extended Cycler Base and Filter HolderNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103702Fluid Detection SystemNXSTAGE MEDICAL, INC.KOC2026-04-22
04987671100627Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
24987671100621Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
04987671100658Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
008408611023655008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611024645008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023625008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023795008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023865008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611024615008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
04987671400000Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2023-08-28
B144MPC825S0Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
B144MPC825S1Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
00840861102259CombiSet SMARTECHFresenius Medical Care Renal Therapies Group, LLCKOC2020-11-17
00840861102266CombiSet SMARTECHFresenius Medical Care Renal Therapies Group, LLCKOC2020-11-17
04987671201102BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
24987671201106BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
00842289102613Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
10842289102610Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
00865165000209HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-12
00865165000216HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-12
00865165000223HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-03
0088893702095316G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702096016G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702099117G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702100417G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04