Hybrid Dressing
The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(10 cm x 30 cm) , UP-D1520(15 cm x 20 cm) , UP-D1530(15 cm x 30…
The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(10 cm x 30 cm) , UP-D1520(15 cm x 20 cm) , UP-D1530(15 cm x 30 cm), XLR8 Port Pad (XP-1012, XP-1013) and 1 piece transparent film 26 cm x 30 cm cut into 5 pieces is a single patient use, disposable, non-invasive kit designed to be used along with recommended Genadyne NPWT pumps. The kit is intended to be used on moderate to low severity wounds.
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 |
| Record published | 2025-12-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| 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 |
|---|---|---|
| UP-D1020/5 | In distribution | |
| UP-D1530 | In distribution | |
| UP-D1520/5 | In distribution | |
| UP-D1040 | In distribution | |
| UP-D1050/5 | In distribution | |
| UP-D1040/5 | In distribution | |
| UP-D1530/5 | In distribution | |
| UP-D1030 | In distribution | |
| UP-D1030/5 | In distribution | |
| UP-D1520 | In distribution | |
| UP-D1020 | In distribution | |
| UP-D1050 | 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.