Consulting Wallah › Device Explorer › Other devices › Non-antimicrobial wound irrigation solution, salin
Device Explorer · FDA GUDID · GMDN 64871

Non-antimicrobial wound irrigation solution, saline

A solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications

US‑registered devices57in commercial distribution
Companies17labelers on GUDID
Single‑use86%of device records
Sterile96%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Nurse Assist, Inc.1628%
Sensimedical Llc814%
Anexa Biomedical, Inc.611%
Amsino International, Inc.59%
Becton, Dickinson And Company47%
Medline Industries, Inc.47%
Owens & Minor Distribution, Inc.35%
Winchester Laboratories Lllp24%

Top labelers

CompanyDevicesShare
Nurse Assist, Inc.1628%
Sensimedical Llc814%
Anexa Biomedical, Inc.611%
Amsino International, Inc.59%
Becton, Dickinson And Company47%
Medline Industries, Inc.47%
Owens & Minor Distribution, Inc.35%
Winchester Laboratories Lllp24%
Venture Healthcare Ltd12%
Caring Mill12%
Neilmed Pharmaceuticals, Inc.12%
Amerx Health Care Corp.12%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Venbase Skin and Wound CleanserStericareSteriCare SolutionsAnexa BiomedicalSENSIMEDICAL Sterile 0.9% Normal Saline, USPCaring Mill Saline Wound WashNeilMed Wound WashAMSure® 0.9% Sodium Chloride lrrigation USP 1000AMSure® 0.9% Sodium Chloride lrrigation USP 500 AMSure® 0.9% Sodium Chloride lrrigation USP 250 AMSure® 0.9% Sodium Chloride lrrigation USP 100 Amerigel Saline Wound WashSignature Care Saline Wound WashLEADERHy-Vee Saline Wound WashPremier Solution Saline Wound Wash

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

FDA product codes

CodeNameDevices
FRODressing, Wound, Drug44
FRODressing, wound, drug12
FQHLavage, Jet5
FQHLAVAGE, JET1
NGTSaline, Vascular Access Flush1
KYZSYRINGE, IRRIGATING (NON DENTAL)1

GMDN & GCC registration

  • GMDN code 64871 · non‑implantable
  • Single‑use 86% · sterile 96% · Rx‑only 75% · OTC 53%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 5Weight (Gram) · 1

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

How many non-antimicrobial wound irrigation solution, saline products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-antimicrobial wound irrigation solution, saline", from 17 companies. The largest labeler is Nurse Assist, Inc. with 28% of records.

Which FDA product codes apply?

FRO (Dressing, Wound, Drug), FRO (Dressing, wound, drug), FQH (Lavage, Jet), FQH (LAVAGE, JET)

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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