FDA.reportPublic FDA data

NxStage Dosing Calculator

Primary DI
M535NX1272
Brand
NxStage Dosing Calculator
Company
NXSTAGE MEDICAL, INC.
Model
NX1272
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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKPSystem, Dialysate Delivery, Single Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKPSystem, Dialysate Delivery, Single PatientGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M535NX1272PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clinical decision management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.

Contacts#

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

Regulatory Flags#

DUNS number
088013219
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G212CM20201WaterCheck2Ibt Scientific LLCFKP2022-01-06
G212CP20101WaterCheckCPIbt Scientific LLCFKP2022-01-06
G212PX20501RenalCheck PXIbt Scientific LLCFKP2022-01-06
G212RC22101WaterCheckRCIbt Scientific LLCFKP2022-01-06
G212HP20401Peracid TestIbt Scientific LLCFKP2022-01-06
00842289101883NX2ME APPNXSTAGE MEDICAL, INC.FKP2019-02-15
00842289101890NX2ME CLINICIAN PORTALNXSTAGE MEDICAL, INC.FKP2019-02-15
M535NX1225NX1379Nx2me Connected Health Nx2me AppNXSTAGE MEDICAL, INC.FKP2015-09-01
M535NX1225NX1380Nx2me Connected Health Nx2me Clinician PortalNXSTAGE MEDICAL, INC.FKP2015-09-01