Consulting Wallah › Device Explorer › Catheters & tubes › Temporary cardiac pacing balloon catheter
Device Explorer · FDA GUDID · GMDN 35854

Temporary cardiac pacing balloon catheter

A sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and

US‑registered devices71in commercial distribution
Companies11labelers on GUDID
Single‑use94%of device records
Sterile90%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Teleflex Incorporated4259%
C. R. Bard, Inc.57%
Edwards Lifesciences Llc57%
St. Jude Medical Cardiovascular Division46%
Hill-Rom, Inc.46%
Becton, Dickinson And Company34%
Argon Medical Devices, Inc.23%
Alpha Medical Instruments23%

Top labelers

CompanyDevicesShare
Teleflex Incorporated4259%
C. R. Bard, Inc.57%
Edwards Lifesciences Llc57%
St. Jude Medical Cardiovascular Division46%
Hill-Rom, Inc.46%
Becton, Dickinson And Company34%
Argon Medical Devices, Inc.23%
Alpha Medical Instruments23%
Bio Trace Medical23%
Stryker Gmbh11%
Bioptimal International Pte. Ltd.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AXSOSPacel™Transvenous Pacing Electrode TraySWAN-GANZARROWN/ASWAN-GANZ PACING TD CATHETERFLEX-TIPALLENBipolar 5FR 110cm Modified-J Shrouded PinsTempo Temporary Pacing Lead, CurvedTempo Temporary Pacing LeadBipolar Pacing Catheter

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 DIRECTED25
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING19
LDFELECTRODE, PACEMAKER, TEMPORARY18
LDFElectrode, Pacemaker, Temporary6
FWZOperating Room Accessories Table Tray4
DYBIntroducer, catheter3

GMDN & GCC registration

  • GMDN code 35854 · non‑implantable
  • Single‑use 94% · sterile 90% · Rx‑only 94% · OTC 6%
  • 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) · 47Length (Centimeter) · 43Outer Diameter (Millimeter) · 3Catheter Length (Centimeter) · 3Length (Millimeter) · 1

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

How many temporary cardiac pacing balloon catheter products are registered in the US?

71 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Temporary cardiac pacing balloon catheter", from 11 companies. The largest labeler is Teleflex Incorporated with 59% of records.

Which FDA product codes apply?

DYG (CATHETER, FLOW DIRECTED), DRF (CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING), LDF (ELECTRODE, PACEMAKER, TEMPORARY), LDF (Electrode, Pacemaker, Temporary)

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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