Consulting Wallah › Device Explorer › Other devices › Haemostasis valve
Device Explorer · FDA GUDID · GMDN 36079

Haemostasis valve

A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary appl

US‑registered devices583in commercial distribution
Companies22labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Galt Medical Corp.22639%
Cordis Us Corp.9116%
Cordis Corporation7012%
Merit Medical Systems, Inc.6110%
Beijing Demax Medical Technology Co., Ltd.488%
Teleflex Incorporated244%
Argon Critical Care Systems Singapore Pte. Ltd.153%
Cook Incorporated112%

Top labelers

CompanyDevicesShare
Galt Medical Corp.22639%
Cordis Us Corp.9116%
Cordis Corporation7012%
Merit Medical Systems, Inc.6110%
Beijing Demax Medical Technology Co., Ltd.488%
Teleflex Incorporated244%
Argon Critical Care Systems Singapore Pte. Ltd.153%
Cook Incorporated112%
Medtronic, Inc.81%
Nipro Vascular Corporation41%
Merit Medical41%
B. Braun Medical Inc.41%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sunmed Haemostatic ValvesDemaxSealing Connector T pieceSealing Connector I PieceSealing Connector Y pieceSJM™GM-30 Accessory KitOKAY® II Y-Connector Set with Extension TubeOKAY® II Y-ConnectorOKAY® II Y-Connector SetSHEATH INTRO POP KIT 9FR L5 MULT=5/50SHEATH INTRO LINK KIT 8FR L5 MULT=5/50SHEATH INTRO LINK KIT 6FR L5 MULT=5/50SHEATH INTRO POP KIT 7FR L5 MULT=5/50SHEATH INTRO LINK KIT 7FR L5 MULT=5/50SHEATH INTRO TRAY KIT 7FR L5 MULT=5/50

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

FDA product codes

CodeNameDevices
DYBIntroducer, Catheter311
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION111
DYBINTRODUCER, CATHETER106
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass73
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass62
OEQAngiography/angioplasty kit12

GMDN & GCC registration

  • GMDN code 36079 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 93% · 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

Catheter Gauge (French) · 296Length (Centimeter) · 12Lumen/Inner Diameter (Millimeter) · 1

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

No closely related category with 50+ devices.

How many haemostasis valve products are registered in the US?

583 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haemostasis valve", from 22 companies. The largest labeler is Galt Medical Corp. with 39% of records.

Which FDA product codes apply?

DYB (Introducer, Catheter), DRE (DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION), DYB (INTRODUCER, CATHETER), DTL (Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass)

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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