Device Explorer · FDA GUDID · GMDN 12741

Haemodialysis needle

A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.

US‑registered devices230in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Nxstage Medical, Inc.8838%
Jms Singapore Pte Ltd6528%
Nipro Medical Corporation4921%
Bain Medical Equipment (Guangzhou) Co., Ltd.177%
Medisystems Corporation83%
Dynarex Corporation21%
Sunder Biomedical Tech. Co., Ltd.10%

Top labelers

CompanyDevicesShare
Nxstage Medical, Inc.8838%
Jms Singapore Pte Ltd6528%
Nipro Medical Corporation4921%
Bain Medical Equipment (Guangzhou) Co., Ltd.177%
Medisystems Corporation83%
Dynarex Corporation21%
Sunder Biomedical Tech. Co., Ltd.10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DORASUNDERButtonHole with SteriPick TWINPACK+ NEEDLE SETmasterguard plus HEMODIALYSIS FISTULA NEEDLE SETButtonHole NEEDLE SETButtonHole with SteriPick NEEDLE SETmasterguard plus TWINPACK+ HEMODIALYSIS FISTULA Medisystems TwinPack Hemodialysis Fistula NeedleMedisystems Hemodialysis Fistula Needle Set withDialysis Safety Syringe w/NeedleNIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLENIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVERNipro SafeTouch TULIP Safety Fistula NeedleNIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLEJMS CAVEO A.V. Fistula Needle SetJMS Sysloc A.V. Fistula Needle Set

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

FDA product codes

CodeNameDevices
FIENeedle, Fistula345
MPBCatheter, Hemodialysis, Non-Implanted19
FOZCatheter,intravascular,therapeutic,short-term less than 30 d18
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 D16
FIENeedle, fistula12
FMINeedle, Hypodermic, Single Lumen2

GMDN & GCC registration

  • GMDN code 12741 · non‑implantable
  • Single‑use 100% · sterile 100% · 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

Needle Gauge (Gauge) · 331Length (Inch) · 266

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

No closely related category with 50+ devices.

How many haemodialysis needle products are registered in the US?

230 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemodialysis needle", from 7 companies. The largest labeler is Nxstage Medical, Inc. with 38% of records.

Which FDA product codes apply?

FIE (Needle, Fistula), MPB (Catheter, Hemodialysis, Non-Implanted), FOZ (Catheter,intravascular,therapeutic,short-term less than 30 d), FOZ (Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 D)

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.

How do I get quotes?

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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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