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Device Explorer · FDA GUDID · GMDN 61630

Haemodialysis/central venous catheterization kit

A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, by: 1) conducting blood from a patient and returning it after extracorporeal circulation, primarily during haemodialysis, but may a

US‑registered devices62in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile92%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Teleflex Incorporated5182%
Guangdong Baihe Medical Technology Co., Ltd.58%
Vygon Corporation58%
Medas Inc12%

Top labelers

CompanyDevicesShare
Teleflex Incorporated5182%
Guangdong Baihe Medical Technology Co., Ltd.58%
Vygon Corporation58%
Medas Inc12%

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

Brand names on the register (sample)

Disposable Hemodialysis Access Catheter SetVYGONMEDADVARROW

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

FDA product codes

CodeNameDevices
NIECATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED40
NIECatheter, hemodialysis, triple lumen, non-implanted13
MPBCatheter, Hemodialysis, Non-Implanted6
OFKPercutaneous atrial catheter kit3
OKEPort introducer kit2

GMDN & GCC registration

  • GMDN code 61630 · non‑implantable
  • Single‑use 100% · sterile 92% · Rx‑only 84% · 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

No structured size data on the register.

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

How many haemodialysis/central venous catheterization kit products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemodialysis/central venous catheterization kit", from 4 companies. The largest labeler is Teleflex Incorporated with 82% of records.

Which FDA product codes apply?

NIE (CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED), NIE (Catheter, hemodialysis, triple lumen, non-implanted), MPB (Catheter, Hemodialysis, Non-Implanted), OFK (Percutaneous atrial catheter kit)

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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