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Device Explorer · FDA GUDID · GMDN 35927

Invasive-pressure external transducer, single-use

A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and trans

US‑registered devices1,190in commercial distribution
Companies8labelers on GUDID
Single‑use69%of device records
Sterile67%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Edwards Lifesciences Llc39433%
Icu Medical, Inc.35430%
Becton, Dickinson And Company13812%
Navilyst Medical, Inc.12010%
Medline Industries, Inc.11610%
Argon Critical Care Systems Singapore Pte. Ltd.363%
Unimed Medical Supplies, Inc.171%
Centurion Medical Products Corporation151%

Top labelers

CompanyDevicesShare
Edwards Lifesciences Llc39433%
Icu Medical, Inc.35430%
Becton, Dickinson And Company13812%
Navilyst Medical, Inc.12010%
Medline Industries, Inc.11610%
Argon Critical Care Systems Singapore Pte. Ltd.363%
Unimed Medical Supplies, Inc.171%
Centurion Medical Products Corporation151%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRUWAVETRUWAVE, VAMP JRTRUWAVE, VAMPTruWave, VAMPTRUWAVE X 3 (3 CC)/VAMP PLUS (215 CM)TRUWAVE, VAMP PLUSTRUWAVE, VAMP JR.TRUWAVE X 2 (3 CC) /VAMP 88 IN (225 CM)TRUWAVE (3 CC) /VAMP 78 IN (200 CM)T005086ATRUWAVE X 3 (3 CC)VOLUMEVIEWTRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)TRUWAVE (3 CC) /VAMP 88 IN (225 CM)TRUWAVE X 2 (3 CC) /VAMP 86 IN (220 CM)PRESSURE MONITORING SET

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

FDA product codes

CodeNameDevices
DXOTRANSDUCER, PRESSURE, CATHETER TIP352
DRSTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR260
IKDCABLE, ELECTRODE146
DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR145
DXOTransducer, Pressure, Catheter Tip132
DRSTransducer, blood-pressure, extravascular95

GMDN & GCC registration

  • GMDN code 35927 · non‑implantable
  • Single‑use 69% · sterile 67% · Rx‑only 98% · 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

Length (Feet) · 119Total Volume (Milliliter) · 118Length (Inch) · 104Length (Centimeter) · 72

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

No closely related category with 50+ devices.

How many invasive-pressure external transducer, single-use products are registered in the US?

1,190 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Invasive-pressure external transducer, single-use", from 8 companies. The largest labeler is Edwards Lifesciences Llc with 33% of records.

Which FDA product codes apply?

DXO (TRANSDUCER, PRESSURE, CATHETER TIP), DRS (TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR), IKD (CABLE, ELECTRODE), DPT (PROBE, BLOOD-FLOW, EXTRAVASCULAR)

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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