Consulting Wallah › Device Explorer › Dialysis & renal › Haemodialysis concentrate
Device Explorer · FDA GUDID · GMDN 35849

Haemodialysis concentrate

A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It

US‑registered devices628in commercial distribution
Companies17labelers on GUDID
Single‑use96%of device records
Sterile1%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Diasol, Inc.16226%
Rockwell Medical, Inc.14623%
Nipro Renal Solutions Usa Corporation6410%
Edlaw Pharmaceuticals, Inc.6410%
Fresenius Medical Care Renal Therapies Group, Llc457%
Di-Chem, Incorporated427%
Dimesol Usa, Llc284%
Nxstage Medical, Inc.284%

Top labelers

CompanyDevicesShare
Diasol, Inc.16226%
Rockwell Medical, Inc.14623%
Nipro Renal Solutions Usa Corporation6410%
Edlaw Pharmaceuticals, Inc.6410%
Fresenius Medical Care Renal Therapies Group, Llc457%
Di-Chem, Incorporated427%
Dimesol Usa, Llc284%
Nxstage Medical, Inc.284%
Medivators Inc.163%
B. Braun Medical Inc.81%
Fresenius Medical Care Holdings, Inc.61%
Global Scientific Technologies61%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RCDS-CARTBiCartSol-Cart B®B.BRAUNAcid Dissolution SystemTablo Hemodialysis ConcentrateNaturaLyteGranuFloCitrasate DryCitrasateBibagCitric CompleteMedicaLyteMedicaPureCitraPureDri-Sate

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)526
KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)72
FKQSystem, Dialysate Delivery, Central Multiple Patient60
FKRSubsystem, Proportioning28
MMYLIPOPROTEIN, LOW DENSITY, REMOVAL1
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valv1

GMDN & GCC registration

  • GMDN code 35849 · non‑implantable
  • Single‑use 96% · sterile 1% · Rx‑only 74% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Pound) · 67Weight (Gram) · 24Total Volume (Milliliter) · 12Total Volume (Gallon) · 7Total Volume (Liter) · 6

Use these as the dimensions to specify in a tender line.

How many haemodialysis concentrate products are registered in the US?

628 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemodialysis concentrate", from 17 companies. The largest labeler is Diasol, Inc. with 26% of records.

Which FDA product codes apply?

KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), KPO (DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)), FKQ (System, Dialysate Delivery, Central Multiple Patient), FKR (Subsystem, Proportioning)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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