Consulting Wallah › Device Explorer › Catheters & tubes › Pulmonary artery balloon catheter, non-electrical
Device Explorer · FDA GUDID · GMDN 35889

Pulmonary artery balloon catheter, non-electrical

A flexible, non-electrical tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian), and advanced from the superior vena cava to the pulmonary artery, to me

US‑registered devices80in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Teleflex Incorporated4556%
Icu Medical, Inc.2126%
Alpha Medical Instruments1012%
Argon Critical Care Systems Singapore Pte. Ltd.45%

Top labelers

CompanyDevicesShare
Teleflex Incorporated4556%
Icu Medical, Inc.2126%
Alpha Medical Instruments1012%
Argon Critical Care Systems Singapore Pte. Ltd.45%

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

Brand names on the register (sample)

ICU MedicalCRITICATH(TM) SP5337H MONITORING CATHETERCRITICATH(TM) SP5327H MONITORING CATHETERCRITICATH(TM) SP5325HL MONITORING CATHETERCRITICATH(TM) SP5325H MONITORING CATHETERARROWAngiographic 5fr 80cm C-tipWedge Pressure 7fr 90cm Modified J-tipWedge Pressure 7fr 110cm S-tipWedge Pressure  6fr 80cm Modified J-tipWedge Pressure  6fr 110cm Standard TipWedge Pressure 6fr 110cm S-tipWedge Pressure  6fr 110cm S-tipWedge Pressure 5fr 60cm Modified J-tipWedge Pressure 5fr 110cm Modified J-tip(StandardWedge Pressure 4fr 60cm Modified J-tip

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

FDA product codes

CodeNameDevices
DYGCATHETER, FLOW DIRECTED48
DQECatheter, oximeter, fiber-optic21
DQOCatheter, Intravascular, Diagnostic21
KRBPROBE, THERMODILUTION1
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC1

GMDN & GCC registration

  • GMDN code 35889 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 91% · 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) · 38Length (Centimeter) · 38

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

How many pulmonary artery balloon catheter, non-electrical products are registered in the US?

80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary artery balloon catheter, non-electrical", from 4 companies. The largest labeler is Teleflex Incorporated with 56% of records.

Which FDA product codes apply?

DYG (CATHETER, FLOW DIRECTED), DQE (Catheter, oximeter, fiber-optic), DQO (Catheter, Intravascular, Diagnostic), KRB (PROBE, THERMODILUTION)

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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