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NxStage Express Fluid Warmer

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

Ref FW-300-WWModel Fluid Warmer Product code KDIEMDN F9080

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-M535FW300WW0 Basic UDI-DIDate27 Jun 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-M535FW300WW0 Basic UDI-DIDate27 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberM535FW300WW0 UDI-DIDate1 Sep 2015ListedStatusListed
United StatesFDA 510(k) 510(k) NumberK140623 Date16 Jun 2014IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Trade Name
NxStage Express Fluid Warmer EUDAMED
Express Fluid Warmer GUDID
Generic Name
Conduction blood/fluid warmer
Model / Reference
FW-300-WW, Fluid Warmer
Primary DI / UDI-DI
M535FW300WW0, 00842289103764
Basic UDI-DI
B-M535FW300WW0, 08422891FLUIDWARMERZQ
FDA Product Code
KDI
EMDN Code
F9080 Dialysis devices - other accessories
GMDN Term
Conduction blood/fluid warmer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5860
Market of Registration
Northern Ireland
Germany
Commercial Distribution
Not in Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (5)

  • EUDAMED c44dfd3c-f291-4ab9-98ea-dd4729b779c4 61 fields · synced 23 Oct 2026
  • FDA UDI 6e39873b-aef4-4cdd-a079-0c04d620ce1f 35 fields · synced 30 May 2026
  • FDA UDI bc827b61-12d9-440c-8c4d-fd493849e54d 34 fields · synced 22 Oct 2026
  • EUDAMED 00842289103764|08422891FLUIDWARMERZQ 61 fields · synced 24 Oct 2026
  • FDA 510(k) K140623 1 fields · synced 18 May 2026