Consulting Wallah › Device Explorer › Dialysis & renal › Haemodialysis dialysate solution
Device Explorer · FDA GUDID · GMDN 61616

Haemodialysis dialysate solution

A sterile, ready-to-use solution with an electrolyte composition similar to that of blood (i.e., a dialysate) intended to exchange solutes with blood across a semi-permeable membrane. It is used within a haemodialysis system to remove metabolic wastes from the

US‑registered devices73in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Nxstage Medical, Inc.3852%
Fresenius Medical Care Renal Therapies Group, Llc1825%
Baxter International Inc.1419%
Haemopharm Biofluids Srl23%
Baxter Healthcare Corporation11%

Top labelers

CompanyDevicesShare
Nxstage Medical, Inc.3852%
Fresenius Medical Care Renal Therapies Group, Llc1825%
Baxter International Inc.1419%
Haemopharm Biofluids Srl23%
Baxter Healthcare Corporation11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PrismaSATENxStage PureFlow SolutionNxStage PureFlow-B SolutionBicarbyPureFlowPRISMASATEHMB32NxStage PureFlow B SolutionPUREFLOW DIALYSATE

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)57
KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)17

GMDN & GCC registration

  • GMDN code 61616 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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

Total Volume (Milliliter) · 20

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How many haemodialysis dialysate solution products are registered in the US?

73 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemodialysis dialysate solution", from 5 companies. The largest labeler is Nxstage Medical, Inc. with 52% of records.

Which FDA product codes apply?

KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), KPO (DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER))

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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