MicroDoc Npwt System
MicroDoc NPWT System, Each, with 15cm x 20cm (10cm x 15cm) ComforTech+ Dressings
8manufacturers in China registered for this device type
26catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Pensar Medical, 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, Manufacturer |
| 510(k) | K200223 |
| Record published | 2024-09-12 |
| Record revised | 2024-08-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8463550 4015 | In distribution | |
| 8463550 4002 | In distribution | |
| 8463550 5001 | In distribution | |
| 8463550 5012 | In distribution | |
| 8463550 4012 | In distribution | |
| 8463550 5003 | In distribution | |
| 8463550 5007 | In distribution | |
| 8463550 4017 | In distribution | |
| 8463550 5013 | In distribution | |
| 8463550 5006 | In distribution | |
| 8463550 5002 | In distribution | |
| 8463550 4004 | In distribution | |
| 8463550 5004 | In distribution | |
| 8463550 4016 | In distribution | |
| 8463550 4003 | In distribution | |
| 8463550 4013 | In distribution | |
| 8463550 4005 | In distribution | |
| 8463550 4001 | In distribution | |
| 8463550 5011 | In distribution | |
| 8463550 5016 | In distribution | |
| 8463550 4014 | In distribution | |
| 8463550 5017 | In distribution | |
| 8463550 4007 | In distribution | |
| 8463550 4011 | In distribution | |
| 8463550 4006 | In distribution | |
| 8463550 5014 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200223 | 2020-10-23 |
| K150960 | 2016-12-01 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2012-08-31 | Class II | Device Design | Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit’s display screen. | 919 units | 2017-12-27 |
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.