Consulting Wallah › Device Explorer › Dialysis & renal › Haemodialysis bicarbonate solution preparation mix
Device Explorer · FDA GUDID · GMDN 36345

Haemodialysis bicarbonate solution preparation mixer

An electrically-powered unit intended to mix a bicarbonate concentrate(s), commonly in powder form, with water to produce a bicarbonate haemodialysis solution. It typically includes tanks with connection hoses, controls and display; some types may include solu

US‑registered devices55in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Mar Cor Purification, Inc.3462%
Better Water, Llc1324%
Ameriwater, Llc713%
Medical Solutions International, Inc.12%

Top labelers

CompanyDevicesShare
Mar Cor Purification, Inc.3462%
Better Water, Llc1324%
Ameriwater, Llc713%
Medical Solutions International, Inc.12%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AmeriWater 00BCMD100AmeriWater 00BCMD55AmeriWater 00BCM100AmeriWater 00BCM55AmeriWater 00BC100-200 Bicarb Mix and DistributiAmeriWater 00BC100-100 Bicarb Mix and DistributiAmeriWater 00BC55-55 Bicarb Mix and DistributionMCB SeriesSDS Bicarb SystemsPSDS Bicarb SystemsBICARB, SINGLE, 60, MIX-ONLYBICARB, SINGLE, 60, MIX/DELBICARB, SINGLE, 100, MIX/DEL, SPBICARB, SINGLE, 100, MIX-ONLYBICARB, SINGLE, 100, MIX/DELBICARB, DUAL, 60, MIX/DEL, EDUCTOR

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

FDA product codes

CodeNameDevices
FINTank, Holding, Dialysis55

GMDN & GCC registration

  • GMDN code 36345 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 98% · 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

Height (Inch) · 37Depth (Inch) · 37Width (Inch) · 37Weight (Pound) · 13

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

How many haemodialysis bicarbonate solution preparation mixer products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemodialysis bicarbonate solution preparation mixer", from 4 companies. The largest labeler is Mar Cor Purification, Inc. with 62% of records.

Which FDA product codes apply?

FIN (Tank, Holding, Dialysis)

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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