Singapore HSA registration DE0013678
KCI V.A.C.Ulta™ Negative Pressure Wound Therapy System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0013678
- Registration Date
- August 23, 2013
- Change Notification Approval Date
- February 01, 2024
- Retention Due Date
- August 22, 2025
Product description
V.A.C. Ulta Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system that provides negative pressure wound therapy with an instillation option. V.A.C. Ulta NPWT System with and without instillation is indicated for patients with chronic, acute, traumatic, sub acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts. NPWT in the absence of instillation may also be used for the temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to,abdominal compartment syndrome. The management of the environment of closed surgical incisions and surrounding intact skin in patients at risk for development post-operative complications, such as infection, by maintaining a closed environment via the application of a NPWT system to the incision.
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.® Dermatac™ Drape V.A.C.® Dermatac™ Drape and V.A.C. ® GRANUFOAM™ Large Dressing Kit V.A.C.® Dermatac™ Drape and V.A.C. ® Granufoam™ Medium Dressing Kit V.A.C.® Dermatac™ Drape and V.A.C.® Granufoam™ Small Dressing Kit V.A.C.® Dermatac™ Drape and V.A.C. ® GRANUFOAM™ Large Dressing Kit V.A.C.® Dermatac™ Drape and V.A.C. ® Granufoam™ Medium Dressing Kit V.A.C.® Dermatac™ Drape and V.A.C.® Granufoam™ Small Dressing Kit 500 mL Canister (with gel) for INFOV.A.C.™ and V.A.C.ULTA™ Therapy Systems (10-pack) 500 mL Canister (with gel) for INFOV.A.C.™ and V.A.C.ULTA™ Therapy Systems (5-pack) 500 mL Canister (without gel) for INFOV.A.C.™ and V.A.C.ULTA™ Therapy Systems (10-pack) 500 mL Canister (without gel) for INFOV.A.C.™ and V.A.C.ULTA™ Therapy Systems (5-pack) PrevenaTM Peel & PlaceTM Dressing, 20cm Prevena™ Peel & Place™ Dressing, 13cm Prevena™ Customizable™ Dressing V.A.C. Ulta Therapy Unit V.A.C. VeraT.R.A.C. Duo Tube Set V.A.C. VeraLink Cassette V.A.C. VERAFLO CLEANSE CHOICE Dressing, Large V.A.C. VERAFLO CLEANSE CHOICE Dressing, Medium V.A.C. VeraFlo Cleanse Dressing Medium V.A.C. VeraFlo Dressing Medium V.A.C. VeraFlo Dressing Small
- Model Identifier(s)
- DTAC10LDP DTGF05PKL DTGF05PKM DTGF05PKS DTGF10PKL DTGF10PKM DTGF10PKS M8275063/10 M8275063/5 M8275071/10 M8275071/5 PRE1055 PRE1155 PRE2055 ULTDEV01/UK ULTDUO0500 ULTLNK0500 ULTVCC05LG ULTVCC05MD ULTVCL05MD ULTVFL05MD ULTVFL05SM
About this record
Access comprehensive regulatory information for KCI V.A.C.Ulta™ Negative Pressure Wound Therapy System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0013678 and owned by KCI USA, Inc.. The device was registered on August 23, 2013.
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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