PVA Foam Kit Large
The Genadyne PVA foam kit provides the wound dressing components used with an A4-XLR8 negative pressure wound therapy system. White polyvinyl alcohol foam fills the wound, transparent film…
The Genadyne PVA foam kit provides the wound dressing components used with an A4-XLR8 negative pressure wound therapy system. White polyvinyl alcohol foam fills the wound, transparent film forms a sealed covering, and the XLR8 Port connects the dressing to the therapy tubing.
The large kit contains white PVA foam, an XLR8 Port and transparent film. Each component is individually packaged, sealed and sterilized before being assembled into the kit. The foam is sterilized by gamma radiation, while the port and film are sterilized with ethylene oxide.
Listed Item
The Genadyne PVA Foam Kit Large consists of a XLR8 Port, two XLR8 Transparent Film and a White PVA Foam Large. Each component are packaged, sealed and sterilized individually and then bagged into a kit.
Wound Applications
The dressing kit requires a compatible Genadyne A4-XLR8 wound vacuum system. Its wound applications include pressure, diabetic and venous ulcers, traumatic wounds, postoperative or dehisced surgical wounds, and skin flaps or grafts.
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shanghai ISO Medical Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Lightstone Medical Products (Ningbo) Co Ltd | Ningbo | Zhejiang | Specification developer | 3 |
Record
| Listed by | Genadyne Biotechnologies, Inc., United States |
|---|---|
| FDA product code | OMP |
| Device type | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K142646 |
| Record published | 2016-09-24 |
| Record revised | 2020-06-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PVA-LFOAM1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 57 |
| Pico | Smith & Nephew, Inc. | 57 |
| Negative Pressure Wound Therapy Powered Suction Pump | Carilex Medical, Inc. | 43 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| extriCARE | Oakwell Distribution, Inc. | 32 |
| Renasys | Smith & Nephew, Inc. | 27 |
| MicroDoc Npwt System | Pensar Medical | 26 |
| ExtriCARE | Alleva Medical Ltd | 22 |
| Vcare Alpha | I.V.T. Medical Ltd | 19 |
| V.A.C.® Granufoam™ | KCI USA, Inc. | 19 |
| Avance | Mölnlycke Health Care AB | 18 |
| Avance® Solo | Mölnlycke Health Care AB | 17 |
Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253429 | 2026-03-12 |
| K233614 | 2024-12-23 |
| K221888 | 2023-06-12 |
| K221891 | 2022-12-14 |
| K210107 | 2022-06-01 |
| K190028 | 2020-01-15 |
| K182722 | 2019-09-27 |
| K180840 | 2018-11-30 |
| K161599 | 2017-04-06 |
| K143726 | 2015-06-19 |
| K142646 | 2015-04-30 |
| K141961 | 2015-03-26 |
| K141437 | 2014-09-19 |
| K092992 | 2010-06-29 |
| K090638 | 2009-04-29 |
| K082676 | 2008-12-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.