Avelle
Avelle™ Negative Pressure Wound Therapy Dressing 12X41cm
8manufacturers in China registered for this device type
9catalogue numbers in this listing
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 | Convatec, Purchasing Department |
|---|---|
| FDA product code | OMP |
| Device type | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| 510(k) | K180205 |
| Record published | 2022-09-09 |
| Record revised | 2024-12-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Inner carton of 5, shipper of 18, shipper of 21, shipper of 16, inner carton |
| Sizes | Width 12 to 26 cm; length 16 to 41 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 421553 | Width 16 cm | In distribution |
| 422156 | Width 21 cm | In distribution |
| 421554 | Width 12 cm | In distribution |
| 422285 | In distribution | |
| 422157 | Width 26 cm | In distribution |
| 422155 | Width 12 cm | In distribution |
| 421552 | Width 16 cm | In distribution |
| 446650 | In distribution | |
| 421555 | Width 12 cm | 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
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.