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PureFlow SL Dialysate Sack Concentrate (SAK-407-A)

by NxStage Medical, Inc. United States EUDAMED510(k)GUDID

Ref SAK-407-A510(k) K111174

Product code FKREMDN F040202

Overview

The PureFlow SL Dialysate Sack Concentrate (SAK-407-A) is a sterile, single-use concentrate for the preparation of dialysate solutions, classified under nomenclature code F040202. It is designed to be mixed with water to create a solution used in hemodialysis procedures, providing essential electrolyte and buffer components for patient treatment.

This concentrate is supplied as a sterile, non-reusable product intended for use in a clinical setting. It is packaged under controlled conditions and requires dilution with sterile water before administration. The device holds FDA 510K and MDD authorizations, adhering to regulatory standards for Class IIb medical devices. Storage and handling must comply with manufacturer guidelines to maintain sterility and efficacy.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-M535SAK407A0 Basic UDI-DIDate9 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberM535SAK407A0 UDI-DIDate30 Oct 2015ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK140571 Date15 May 2014IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring (legacy directive)
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Recalls

10 recalls · FDA

    • Terminated Z-0811-2018 FDA Class II initiated 29 Jan 2018

    May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.

  • 8 recalls, same reason

    • Terminated Z-1855-2014 FDA Class II initiated 14 May 2014
    • Terminated Z-1859-2014 FDA Class II initiated 14 May 2014
    • Terminated Z-1858-2014 FDA Class II initiated 14 May 2014
    • Terminated Z-1857-2014 FDA Class II initiated 14 May 2014
    • Terminated Z-1860-2014 FDA Class II initiated 14 May 2014
    • Terminated Z-1856-2014 FDA Class II initiated 14 May 2014
    • Terminated Z-1861-2014 FDA Class II initiated 14 May 2014
    • Terminated Z-1854-2014 FDA Class II initiated 14 May 2014

    SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

    • Terminated Z-0826-2012 FDA Unclassified (pre-2012) initiated 14 Dec 2011

    Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Full name
Nxstage Pureflow Sl Dialysate Sack (Sak) Concentrate
Trade Name
Nxstage Pureflow Sl Dialysate Sack (Sak) Concentrate EUDAMED
Dialysate Sack (SAK) with Concentrate GUDID
Generic Name
Haemodialysis concentrate
Model / Reference
SAK-407-A
Primary DI / UDI-DI
M535SAK407A0
Basic UDI-DI
B-M535SAK407A0
FDA Product Code
FKR
EMDN Code
F040202 Dialysis concentrates, basic solutions, liquid
GMDN Term
Haemodialysis concentrate
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5820
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000026832
Authorised representative
Fresenius Medical Care Deutschland GmbH DE-AR-000009269

Other devices from NxStage Medical, Inc.

See all devices from NxStage Medical, Inc. →

Questions

  • What is the NXSTAGE PUREFLOW SL DIALYSATE SACK (SAK) CONCENTRATE used for in hemodialysis procedures?

    The NXSTAGE PUREFLOW SL DIALYSATE SACK (SAK-407-A) is a sterile, single-use concentrate designed to be mixed with sterile water to create a dialysate solution. This solution provides essential electrolytes and buffer components during hemodialysis, supporting the removal of waste and excess fluids from a patient’s blood.

  • Is the NXSTAGE PUREFLOW SL DIALYSATE SACK (SAK) CONCENTRATE reusable, and how should it be handled to maintain sterility?

    The device is explicitly labeled as non-reusable (REUSABLE: 0) and must be treated as a single-use item. To maintain sterility, it should be stored under controlled conditions as specified by the manufacturer and only used once per patient. Always follow the provided handling guidelines to prevent contamination.

  • What regulatory approvals does the NXSTAGE PUREFLOW SL DIALYSATE SACK (SAK) CONCENTRATE hold, and what classification does it fall under?

    The device holds FDA 510K clearance and adheres to the Medical Device Directive (MDD), classifying it as a Class IIb medical device. This classification aligns with its role in supporting hemodialysis by providing critical components for dialysate preparation.

  • How is the NXSTAGE PUREFLOW SL DIALYSATE SACK (SAK) CONCENTRATE packaged and prepared for use?

    The concentrate is supplied in a sterile, single-use sack (reference SAK-407-A) and must be diluted with sterile water before administration. It is packaged under controlled conditions to ensure sterility and efficacy, requiring adherence to manufacturer guidelines for storage and preparation.

  • What unique identifier (UDI) is associated with the NXSTAGE PUREFLOW SL DIALYSATE SACK (SAK) CONCENTRATE, and how can it be verified?

    The device carries a Basic UDI (B-M535SAK407A0) and a Primary DI (M535SAK407A0) for traceability. These identifiers can be cross-referenced with the UDI database (e.g., FDA’s UDI database or global systems) using the provided UDI-DI Data ULID (01HXEVDHQN1DDGS1QYGNBDG8ZG) to confirm authenticity and compliance.

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 083786df-32d8-42d7-bb38-559dc0e4e17f 85 fields · synced 22 Oct 2026
  • FDA UDI dd425667-4807-49a5-b0d5-9567d0115169 34 fields · synced 30 May 2026
  • FDA 510(k) K080919 1 fields · synced 18 May 2026