PVA Foam Kit Small
The Genadyne PVA Foam Kit Small is a prescription wound dressing kit for use with the Genadyne A4-XLR8 Wound Vacuum System. It supplies white polyvinyl alcohol foam, an XLR8 port and…
The Genadyne PVA Foam Kit Small is a prescription wound dressing kit for use with the Genadyne A4-XLR8 Wound Vacuum System. It supplies white polyvinyl alcohol foam, an XLR8 port and transparent film for delivery of negative pressure wound therapy.
The foam dressing is used as part of a suction system that removes excess wound exudate, infectious material and tissue debris. Supported wound types include pressure ulcers, diabetic or neuropathic ulcers, venous insufficiency ulcers, traumatic wounds, postoperative or dehisced surgical wounds, and skin flaps and grafts.
Listed Item
The Genadyne PVA Foam Kit Small consists of a XLR8 Port, XLR8 Transparent Film and a White PVA Foam Small. Each component are packaged, sealed and sterilized individually and then bagged into a kit.
Kit Components
The port is silicone and the film is polyurethane. The white foam is gamma sterilized, while the port and film are sterilized with ethylene oxide. Components are individually packaged, sealed and sterilized before being assembled into the kit.
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 5) |
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-SFOAM1 | 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.