Cardinal Health
NPWT Black Foam Dressing Kit Occlusion Detection - MEDIUM x15
8manufacturers in China registered for this device type
57catalogue numbers in this listing
2recalls on this code
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 | Cardinal Health 200, LLC, 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 | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2018-05-30 |
| Record revised | 2022-04-15 (version 9) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 10, case of 5, case, case of 15, each |
| Distribution end date | 2025-03-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 68-1132 | In distribution | ||
| 68-1132R | In distribution | ||
| 6701132 | In distribution | ||
| 6708888 | In distribution | ||
| 48-0010 | In distribution | ||
| 47-0010 | In distribution | ||
| 47-1703 | In distribution | ||
| 68-8888 | In distribution | ||
| 6701132R | In distribution | ||
| 48-1701 | Withdrawn | ||
| 47-1751 | Withdrawn | ||
| 47-1751 | Withdrawn | ||
| 47-9600 | Withdrawn | ||
| 47-4000 | Withdrawn | ||
| 48-1230 | Withdrawn | ||
| 47-7100 | Withdrawn | ||
| 47-2000 | Withdrawn | ||
| 48-2500 | Withdrawn | ||
| 47-6500 | Withdrawn | ||
| 47-7000 | Withdrawn | ||
| 47-1702 | Withdrawn | ||
| 47-4500 | Withdrawn | ||
| 47-6000 | Withdrawn | ||
| 6700032 | Withdrawn | ||
| 48-1701-15 | Withdrawn | ||
| 47-9100 | Withdrawn | ||
| 47-6500 | Withdrawn | ||
| 47-2500 | Withdrawn | ||
| 48-4500 | Withdrawn | ||
| 47-1702/15 | 15 | Withdrawn | |
| 48-1703 | Withdrawn | ||
| 47-1700 | 10 | Withdrawn | |
| 48-4100 | Withdrawn | ||
| 47-1701 | 10 | Withdrawn | |
| 48-1702-15 | Withdrawn | ||
| 47-6000 | Withdrawn | ||
| 47-1700/15 | 15 | Withdrawn | |
| 47-1700 | Withdrawn | ||
| 47-9000 | Withdrawn | ||
| 48-2000 | Withdrawn | ||
| 47-1703 | Withdrawn | ||
| 47-9200 | Withdrawn | ||
| 47-7100 | Withdrawn | ||
| 48-4000 | Withdrawn | ||
| 47-1755 | Withdrawn | ||
| 47-1704 | Withdrawn | ||
| 47-4100 | Withdrawn | ||
| 47-1704 | Withdrawn | ||
| 47-1702 | 10 | Withdrawn | |
| 48-1700-15 | Withdrawn | ||
| 48-1702 | Withdrawn | ||
| 47-1701/15 | 15 | Withdrawn | |
| 48-1700 | Withdrawn | ||
| 6702232 | Withdrawn | ||
| 47-1701 | Withdrawn | ||
| 47-7000 | Withdrawn | ||
| 47-1755 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Silverlon Antimicrobial Wound Dressing | Argentum Medical, LLC | 14 |
Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-06-04 | Class II | Nonconforming Material/Component | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. | 1960 | 2025-08-05 |
| 2020-06-04 | Class II | Nonconforming Material/Component | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. | 3000 | 2025-08-05 |
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.