Consulting Wallah › Device Explorer › Dialysis & renal › Haemodialysis blood tubing set, single-use
Device Explorer · FDA GUDID · GMDN 34999

Haemodialysis blood tubing set, single-use

A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood line

US‑registered devices131in commercial distribution
Companies24labelers on GUDID
Single‑use99%of device records
Sterile98%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Molded Products, Inc.1915%
Fresenius Medical Care Holdings, Inc.1713%
Nipro Medical Corporation1612%
B. Braun Medical Inc.108%
Gambro Renal Products, S.A. De C.V.97%
Fresenius Medical Care Renal Therapies Group, Llc75%
Gambro Dasco Spa65%
Bain Medical Equipment (Guangzhou) Co., Ltd.65%

Top labelers

CompanyDevicesShare
Molded Products, Inc.1915%
Fresenius Medical Care Holdings, Inc.1713%
Nipro Medical Corporation1612%
B. Braun Medical Inc.108%
Gambro Renal Products, S.A. De C.V.97%
Fresenius Medical Care Renal Therapies Group, Llc75%
Gambro Dasco Spa65%
Bain Medical Equipment (Guangzhou) Co., Ltd.65%
Sunder Biomedical Tech. Co., Ltd.65%
Outset Medical, Inc.65%
Nikkiso Co.,Ltd.43%
Lifemed Of California43%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SAMI CassetteCartridge Blood SetNARecirculation Adapter/Priming ConnectorBLOOD CIRCUIT SETNovaLineDORABlood Tube SetOxylessBlood Tubing Lines for HemodialysisBLOOD TUBING LINES FOR HEMODIALYSISSUNDERHemodialysis BloodlinesDiapact®RPCLifemed 60 inch Monitor Line

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

FDA product codes

CodeNameDevices
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valv56
FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALV44
KOCAccessories, Blood Circuit, Hemodialysis27
FJKSet, tubing, blood, with and without anti-regurgitation valv13
KDIDialyzer, High Permeability With Or Without Sealed Dialysate11
KOCACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS6

GMDN & GCC registration

  • GMDN code 34999 · non‑implantable
  • Single‑use 99% · sterile 98% · Rx‑only 82% · 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) · 15Weight (Gram) · 1Length (Inch) · 1Length (Centimeter) · 1Lumen/Inner Diameter (Millimeter) · 1Total Volume (Liter) · 1

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

How many haemodialysis blood tubing set, single-use products are registered in the US?

131 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemodialysis blood tubing set, single-use", from 24 companies. The largest labeler is Molded Products, Inc. with 15% of records.

Which FDA product codes apply?

FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valv), FJK (SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALV), KOC (Accessories, Blood Circuit, Hemodialysis), FJK (Set, tubing, blood, with and without anti-regurgitation valv)

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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