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510(k) Data Aggregation
K Number
K211571Device Name
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
Manufacturer
Zhejiang Longterm Medical Technology Co., LTD
Date Cleared
2022-05-31
(375 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Longterm Medical Technology Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Longterm NPWT Foam Dressing Kit is intended to be used along with VCare 1000 -300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Longterm NPWT foam dressing kit is for use in professional healthcare facilities only.
Device Description
Longterm NPWT Foam dressing kit is an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit is composed of black foam dressing, polyurethane (PU) film drape and suction bell.
The foam dressing is used to pack the wound bed, the PU film drape is used to cover the packed wound bed and peri-wound area to create and maintain a sealed environment, the suction bell is served as a conduit between the wound bed and the negative pressure pump to transfer the wound fluid to the canister attached to the pump.
Longterm NPWT Foam dressing kit consists of hydrophobic, reticulated Polyurethane foam, polyurethane film drape coated with acrylic adhesive, suction bell composed of a polyvinyl chloride (PVC) drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent polyurethane film coated with acrylic adhesive. Each component is individually packaged and sterilized. The foam dressing should be changed every 2-3 days depending on the wound condition or according to the local protocol.
The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive.
Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium (18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm.
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K Number
K202823Device Name
Innomed NPWT Silicone Foam Dressing
Manufacturer
Zhejiang Longterm Medical Technology Co., LTD
Date Cleared
2021-12-15
(447 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Longterm Medical Technology Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Innomed NPWT Silicone Foam Dressing is intended to be used along with VCare 1000- 300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.
When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types:
- Chronic
- Acute
- · Traumatic
- Subacute and dehisced wounds
- · Partial-thickness burns,
- · Ulcers (such as diabetic or pressure)
- · Flaps and grafts
The device is for use in professional healthcare facilities only.
Device Description
Innomed NPWT Silicone foam dressing is a single-use device, as an accessory to VCare-1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The NPWT Silicone foam dressing consists of silicone adhesive coated foam dressing attached with a suction bell and fixation film strips.
The silicone foam dressing is comprised of PU film, absorbent pad consisting of polyurethane (PU) foam, absorbent fibre and polyester fabric, a layer silicone adhesive is coated onto the entire surface.
The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a polypropylene luer taper, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive. The suction bell is attached on the silicone foam dressing surface.
Fixations film strips is composed of PU film coated with acrylic adhesive.
Machnism of Action: The silicone adhesive coated foam dressing is used to pack the wound bed and cover periwound area, and the fixation film strips are applied over the outside edges of the dressing to facilitate hold the silicone foam dressing in place and seal the wound bed area. The other end of the attached suction bell is connected to a canister attached to the negative pressure pump, VCare 1000-300S pump, and served as a conduit to transfer the wound exudate to the canister under negative pressure when the pump is turned on.
Innomed NPWT Silicone Foam Dressing is available in 10 sizes: SNPWT-1010 ( 10cm X 10cm ), SNPWT-1020 (10cm X 20cm ), SNPWT-1030 (10cm X 30cm ), SNPWT-1040( 10cm X 40cm ), SNPWT-1515(15cm X 15cm ), SNPWT-1520 (15cm X 20cm ), SNPWT-1530 (15cm X 30cm ), SNPWT-2020 (20cm X 20cm ), SNPWT-2025(20cm X 25cm ), SNPWT-2525(25cm X 25cm )
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K Number
K192478Device Name
LT Antibacterial Alginate with Silver Dressing
Manufacturer
Zhejiang Longterm Medical Technology Co., Ltd.
Date Cleared
2020-06-17
(281 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Zhejiang Longterm Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns.
LT Antibacterial Alginate with Silver Dressing is intended for external use only.
Device Description
LT Antibacterial Alginate with Silver Dressing is an advanced wound care dressing composed of calcium alginate and silver salt (3.5%). The dressing forms a gel when absorbs wound fluid to provide a moist environment and allows intact removal. When in contact with wound fluid, silver ions within the dressing inhibit bacterial growth in the dressing. LT Antibacterial Alginate with Silver Dressing is available in pad and ribbon configurations and various sizes. The pad is used to cover and protect the wound bed and the ribbon is used to pack the wound with cavity.
LT Antibacterial Alginate with Silver Dressing can be cut and layered for various wound shapes and types.
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K Number
K182458Device Name
Longterm NPWT Foam Dressing Kit
Manufacturer
Zhejiang Longterm Medical Technology Co., LTD
Date Cleared
2019-05-23
(255 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Longterm Medical Technology Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The dressing kit is intended to be used along with VCare 1000-300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT foam dressing kit is for use in professional healthcare facilities only.
Device Description
Longterm NPWT dressing kit is a single use device as an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit consists of hydrophobic, reticulated Polyurethane foam, polyurethane film drape coated with acrylic adhesive, suction bell composed of a polyvinyl chloride (PVC) drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent polyurethane film coated with acrylic adhesive. Each component is individually packaged and sterilized.
The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive.
Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium (18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm.
The foam dressing is used to pack the wound bed, the film drape is used to cover the packed wound bed and peri-wound area to create and maintain a sealed environment, the suction bell is served as a conduit between the wound bed and the suction pump to transfer the wound fluid to the canister attached to the suction pump.
The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with the VCare 1000-300S pump after 24 hours.
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