Singapore HSA registration DE0016594
KCI V.A.C.® Dressings
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0016594
- Registration Date
- November 25, 2014
- Change Notification Approval Date
- September 23, 2024
- Retention Due Date
- November 24, 2025
Product description
When used on open wounds, the 3M™ V.A.C.® Dressing Kit with the 3M™ V.A.C.® Therapy System is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types are: acute and subacute dehisced wounds, traumatic wounds, partial-thickness burns, flaps, grafts and chronic diabetic ulcers, pressure ulcers and venous insufficiency ulcers. When used on closed surgical incisions, the 3M™ V.A.C.® Dressing Kit is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. V.A.C. GRANUFOAM Bridge Dressing and V.A.C SIMPLACE Dressing featuring GRANUFOAM Spiral Dressing are used on open wounds only.
Product Owner
- Name
- KCI USA, Inc.
- Short Name
- KCI USA, Inc.
- Address
- 12930 IH 10 West, TX 78249, UNITED STATES
Registrant
- Address
- 10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Importer
- Address
- 10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Model information
- Model Name(s)
- V.A.C.® SIMPLACE™ Dressing Medium Featuring GRANUFOAM™ Spiral Dressing V.A.C.® SIMPLACE™ Dressing Medium Featuring GRANUFOAM™ Spiral Dressing V.A.C.® SIMPLACE™ Dressing Small Featuring GRANUFOAM™ Spiral Dressing V.A.C.® SIMPLACE™ Dressing Small Featuring GRANUFOAM™ Spiral Dressing V.A.C.® GRANUFOAM™ Bridge Dressing V.A.C.® GRANUFOAM™ Bridge Dressing V.A.C.® Simplace™ Ex Dressing – Medium V.A.C.® Simplace™ Ex Dressing – Small V.A.C.® GranuFoam™ Small Dressing with SensaT.R.A.C.™ Technology V.A.C.® GranuFoam™ Small Dressing with SensaT.R.A.C.™ Technology V.A.C.® GranuFoam™ Medium Dressing with SensaT.R.A.C.™ Technology V.A.C.® GranuFoam™ Medium Dressing with SensaT.R.A.C.™ Technology V.A.C.® GranuFoam™ Large Dressing with SensaT.R.A.C.™ Technology V.A.C.® GranuFoam™ Large Dressing with SensaT.R.A.C.™ Technology V.A.C.® GRANUFOAM™ Dressing Featuring SENSAT.R.A.C.™ Technology X-Large
- Model Identifier(s)
- M8275040/10 M8275040/5 M8275041/10 M8275041/5 M8275042/10 M8275042/5 M8275045/5 M8275046/5 M8275051/10 M8275051/5 M8275052/10 M8275052/5 M8275053/10 M8275053/5 M8275065/5
About this record
Access comprehensive regulatory information for KCI V.A.C.® Dressings in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016594 and owned by KCI USA, Inc.. The device was registered on November 25, 2014.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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