Nx2me Connected Health Nx2me Clinician Portal

GUDID M535NX1225NX1380

Medical equipment clinical data interfacing software

Primary Device ID	M535NX1225NX1380
NIH Device Record Key	7b7cfe9d-9c77-4865-be5e-c5d81defe357
Commercial Distribution Discontinuation	2021-06-01
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Nx2me Connected Health Nx2me Clinician Portal
Version Model Number	NX1380
Company DUNS	088013219
Company Name	NXSTAGE MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	M535NX1225NX1380 [Primary]

FKP	System, Dialysate Delivery, Single Patient

Steralize Prior To Use	false
Device Is Sterile	false

00842289103894 - VersiHD with GuideMe Software	2025-10-01
00842289104044 - VersiHD with GuideMe Software	2025-10-01
00842289104051 - VersiHD with GuideMe Software	2025-10-01
M535RFP205WW5 - NxStage PureFlow Solution	2025-07-23
00842289103870 - NXSTAGE CARTRIDGE EXPRESS	2024-08-01
00842289103887 - NXSTAGE CARTRIDGE EXPRESS	2024-08-01
10842289103044 - NxStage PureFlow Solution	2024-04-04
10842289103051 - NxStage PureFlow Solution	2024-04-04