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Device Explorer · FDA GUDID · GMDN 17541

Catheter/overtube balloon inflator, single-use

A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the bal

US‑registered devices984in commercial distribution
Companies48labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Merit Medical Systems, Inc.67468%
Atrion Medical Products, Inc.687%
Medline Industries, Inc.303%
Lepu Medical Technology (Beijing) Co.,Ltd.263%
Navilyst Medical, Inc.212%
Medtronic, Inc.192%
Beijing Demax Medical Technology Co., Ltd.182%
Genoss Co., Ltd.101%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.67468%
Atrion Medical Products, Inc.687%
Medline Industries, Inc.303%
Lepu Medical Technology (Beijing) Co.,Ltd.263%
Navilyst Medical, Inc.212%
Medtronic, Inc.192%
Beijing Demax Medical Technology Co., Ltd.182%
Genoss Co., Ltd.101%
Tianck Medical Co., Ltd.91%
Boston Scientific Corporation71%
Shanghai Kinetic Medical Co., Ltd.61%
Nipro Vascular Corporation61%

Company = labeler of record on GUDID. 48 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NaviAid™ ABCNaviAid™ ABBalloon inflation deviceBalloon InflatorsINT,Force Inflation DeviceSunmed Inflation DeviceSunmed Inflation devicesSunmed Inflation DeviceDemaxBalloon Inflation DeviceElite MedtekKMC Inflation Syringe, 60cm, 30atmKMC Inflation Syringe, 30cm, 30atmKMC Medical Balloon Catheter Syringe PumpBalloon Catheter Syringe PumpBalloon Inflation Devices

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

FDA product codes

CodeNameDevices
OEQAngiography/angioplasty kit512
PTMSyringe, Balloon Inflation, Exempt175
MAVSyringe, Balloon Inflation109
MAVSyringe, balloon inflation77
KOEDilator, Urethral64
DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC40

GMDN & GCC registration

  • GMDN code 17541 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 49% · 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

Pressure (KiloPascal) · 42Length (Centimeter) · 6Pressure (Atmosphere) · 6Length (Millimeter) · 5Total Volume (Milliliter) · 4Pressure (Pound per Square Inch) · 3

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

No closely related category with 50+ devices.

How many catheter/overtube balloon inflator, single-use products are registered in the US?

984 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Catheter/overtube balloon inflator, single-use", from 48 companies. The largest labeler is Merit Medical Systems, Inc. with 68% of records.

Which FDA product codes apply?

OEQ (Angiography/angioplasty kit), PTM (Syringe, Balloon Inflation, Exempt), MAV (Syringe, Balloon Inflation), MAV (Syringe, balloon inflation)

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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