📋 FDA Reference
Multidex Hydrophilic Wound Dressing
Lange Medical Products
Summary: Multidex Hydrophilic Wound Dressing is a wound care product used to manage various types of wounds by maintaining a moist environment. It is typically used by wound care specialists and clinicians in hospitals and outpatient settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K945000 ↗
Decision Date ?
November 17, 1994
Product Code ?
KMF
Device Class ?
Class 1
Evidence ?
419 studies
The Multidex Hydrophilic Wound Dressing was cleared through the FDA 510(k) pathway on November 17, 1994. Manufactured by Lange Medical Products, it is classified as a Class 1 device under product code KMF.
What It Is
The Multidex Hydrophilic Wound Dressing is a wound care product designed to create and maintain a moist wound environment, which is conducive to healing. It is composed of materials that absorb exudate while keeping the wound bed hydrated. This dressing is particularly useful in managing chronic and acute wounds by promoting autolytic debridement and protecting the wound from external contaminants.
FDA-Cleared Indications
- Management of wounds that benefit from a moist wound environment.
- Management of wound exudate while maintaining moisture at the wound bed.
- Use as a protective wound dressing to support the healing process.
Clinical Applications
- Dressing wounds with exudate that require moisture balance.
- Covering acute or chronic wounds when a moist healing environment is appropriate.
- Protecting a wound from external contamination with a secondary dressing when indicated.
- Use in hospital, outpatient, clinic, or home-care wound management under clinical direction.
Practical Considerations
- Select the dressing size and application method according to the wound dimensions, location, depth, and amount of exudate.
- A secondary dressing may be needed to secure the product and contain drainage.
- Change the dressing according to the wound condition, product instructions, and the amount of exudate.
- Assess the wound regularly for infection, deterioration, excessive drainage, maceration, or allergic or local skin reactions.
- No MRI-specific safety information is provided in the supplied FDA record; confirm the current product labeling before MRI, and remove or manage the dressing as clinically appropriate.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Multidex Hydrophilic Wound Dressing used for?
It is used to manage wounds by maintaining a moist environment that promotes healing and protects against infection.
What specialties typically use this device?
Wound care specialists, including nurses and dermatologists, typically use this device in various healthcare settings.
What are the FDA-cleared indications?
The dressing is indicated for use in wounds that require moisture management and protection to facilitate healing.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.