Negative Pressure Wound Therapy System - Vietnam Registration 220000642/PCBB-HCM
Access comprehensive regulatory information for Negative Pressure Wound Therapy System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 220000642/PCBB-HCM and manufactured by Theo theo phụ lục.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including KCI Manufacturing, Guangdong Meiji Biotechnology Co,. Ltd., and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
220000642/PCBB-HCM
000.00.19.H29-220110-0041
Theo theo phụ lục
Theo phụ lục
Technical Details
The V.A.C.ULTA™ Wound Therapy System is an integrated wound management system that provides: •Negative Pressure Wound Therapy (NPWT) combined with a transmission solution. For the non-transmission NPWT system, it creates a conducive environment for the second or third phase healing (delayed primary healing), by evaluating and treating the initial wound (preparing the wound bed for closure), reducing edema, promoting granulation tissue formation and increasing blood flow, while simultaneously removing exudate and reducing the risk of infection. •The integrated transmission solution system is indicated for patients requiring negative pressure drainage and controlled delivery of wound cleansing solutions and wound dressings at the wound bed. The V.A.C.ULTA™ Wound Therapy System, both with and without transmission, is indicated for the treatment of chronic and acute wounds, including those resulting from trauma, sub-acute wounds, dehisced surgical wounds, partial thickness burns (burns of the second degree), ulcers (diabetic ulcers, pressure ulcers, or venous ulcers), and skin grafts and flaps. •The non-transmission NPWT system can also be used in the following scenarios: •Creating a temporary bridge in open abdomen surgery when the wound cannot close in the primary phase and/or when the abdomen needs to be opened multiple times, or when the abdomen is open and the internal organs are exposed (including but not limited to, the condition of abdominal compartment syndrome). The area of care should be the area that is closely monitored in the intensive care unit, e.g., ICU. The foam pad for open abdomen wounds is most commonly used in the operating room. •The area around the closed surgical wound and the surrounding healed skin should be managed in patients at risk for post-surgical complications (e.g., infection), by using the negative pressure wound therapy system to create a closed environment around the wound. The foam bandage of the PREVENA™ Incision Dressing (PREVENA™ Incision Dressing) contains silver, which helps reduce the growth of bacteria at the wound site.
Dates and Status
Mar 07, 2022
Wound exudate container for the negative pressure wound therapy system
Drain canister
Guangdong Meiji Biotechnology Co,. Ltd.
240000515/PCBA-HN
Negative Pressure Wound Therapy System
3M™ ActiV.A.C.™ Therapy System
KCI Manufacturing
170802

