Consulting Wallah › Device Explorer › Other devices › Negative-pressure wound therapy system, electric,
Device Explorer · FDA GUDID · GMDN 58202

Negative-pressure wound therapy system, electric, single-use

A portable assembly of devices designed to apply suction to help heal traumatic and chronic skin wounds (e.g., grafts, incisions, burns, ulcers) with low to moderate levels of exudate. It typically consists of an electrically-powered vacuum pump, a highly-abso

US‑registered devices192in commercial distribution
Companies7labelers on GUDID
Single‑use98%of device records
Sterile58%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Smith & Nephew Medical Limited6936%
Genadyne Biotechnologies Inc.3719%
Kci Usa, Inc.3619%
Pensar Medical, Llc2815%
New Horizon Healthcare Management Llc105%
Mölnlycke Health Care Ab84%
Applied Tissue Technologies Llc42%

Top labelers

CompanyDevicesShare
Smith & Nephew Medical Limited6936%
Genadyne Biotechnologies Inc.3719%
Kci Usa, Inc.3619%
Pensar Medical, Llc2815%
New Horizon Healthcare Management Llc105%
Mölnlycke Health Care Ab84%
Applied Tissue Technologies Llc42%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Avance®Avance® SoloPico 14PICOPICO™ MULTISITE 20x25cmPICO™ MULTISITE 15x20cmMicroDoc NPWT SystemMicroDoc NPWT Control UnitPWD™ Platform Wound Dressing Negative Pressure SPWD™ Platform Wound Dressing Negative Pressure SPWD™ Platform Wound Dressing Negative Pressure SViz™ Wound Visualization Negative Pressure WoundViz™ Wound DressingViz™ Wound Dressing3M™ Prevena Restor™ Adaptiform™PREVENA RESTOR AXIO•FORM™

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

FDA product codes

CodeNameDevices
OMPNegative Pressure Wound Therapy Powered Suction Pump181
QFCNegative Pressure Wound Therapy device for reduction of woun41
OMPnegative pressure wound therapy Powered suction pump11

GMDN & GCC registration

  • GMDN code 58202 · non‑implantable
  • Single‑use 98% · sterile 58% · Rx‑only 77% · 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 (Centimeter) · 41Width (Centimeter) · 41Width (Inch) · 41Length (Inch) · 41

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

How many negative-pressure wound therapy system, electric, single-use products are registered in the US?

192 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Negative-pressure wound therapy system, electric, single-use", from 7 companies. The largest labeler is Smith & Nephew Medical Limited with 36% of records.

Which FDA product codes apply?

OMP (Negative Pressure Wound Therapy Powered Suction Pump), QFC (Negative Pressure Wound Therapy device for reduction of woun), OMP (negative pressure wound therapy Powered suction pump)

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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