📋 FDA Reference
Multidex Plus Hydrophilic Wound Dressing
Lange Medical Products
Summary: The Multidex Plus Hydrophilic Wound Dressing is a medical device used for wound management. It is typically utilized by healthcare professionals in various settings to promote healing in patients with different types of wounds.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K955399 ↗
Decision Date ?
February 7, 1996
Product Code ?
KMF
Device Class ?
Class 1
Evidence ?
419 studies
The Multidex Plus Hydrophilic Wound Dressing was cleared through the FDA 510k pathway on February 7, 1996. Manufactured by Lange Medical Products, it is classified as a Class 1 device under product code KMF.
What It Is
The Multidex Plus Hydrophilic Wound Dressing is a specialized wound care product designed to maintain a moist environment conducive to healing. It is hydrophilic, meaning it can absorb exudate while keeping the wound bed moist, which is crucial for optimal wound healing. The dressing is typically used in various types of wounds, including ulcers, surgical wounds, and pressure sores, to promote faster and more effective healing.
FDA-Cleared Indications
- Management of wounds requiring a moist healing environment.
Clinical Applications
- Covering and managing wounds in clinical or home-care settings.
- Maintaining moisture at the wound surface during healing.
- Managing wound exudate with an absorbent hydrophilic dressing.
- Use as part of a broader wound-care plan that may include cleansing, debridement, compression, or other clinically appropriate treatment.
Practical Considerations
- Select a dressing size that covers the wound appropriately and follow the product labeling and clinician instructions for application and replacement.
- The dressing is intended for external wound care; the wound should be assessed for infection, ischemia, necrosis, excessive drainage, and other conditions requiring additional treatment.
- It may be used with other wound-care measures when clinically appropriate, including compression therapy for selected venous wounds.
- The FDA record identifies the device as a Class I product under product code KMF; specific contraindications, precautions, storage requirements, and change intervals should be checked in the current package labeling.
- MRI safety is not established by the provided FDA record. Confirm the current labeling before use during MRI or in the MRI environment.
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 Plus Hydrophilic Wound Dressing used for?
It is used for managing wounds by maintaining a moist environment to promote healing, particularly in chronic and acute wounds.
What specialties typically use this device?
Specialties such as dermatology, surgery, and wound care nursing commonly use this device for wound management.
What are the FDA-cleared indications?
The device is indicated for use in wounds requiring a moist healing environment, such as diabetic ulcers and pressure sores.
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.