Invia White Foam Npwt
Invia White Foam is a sterile polyvinyl alcohol dressing used with the Invia Foam Dressing Kit with FitPad and Invia Motion or Invia Liberty negative pressure wound therapy systems.…
Invia White Foam is a sterile polyvinyl alcohol dressing used with the Invia Foam Dressing Kit with FitPad and Invia Motion or Invia Liberty negative pressure wound therapy systems. Healthcare professionals use it in acute, extended and home care settings for wounds requiring negative pressure therapy.
The foam has an open-cell, hydrophilic structure and is supplied moistened with sterile water. It allows fluid to pass through and away from the wound bed as the connected therapy system applies sub-atmospheric pressure. It can be cut to fit the wound.
Listed Item
PVA foam dressing – large
Therapy Compatibility
The dressing supports constant or intermittent negative pressure therapy. It may replace or supplement the wound dressing in the compatible FitPad kit; the listed large dressing is one of two available foam sizes.
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 | Medela 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K180415 |
| Record published | 2018-11-26 |
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, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 087.6304 | In distribution | |
| 087.6303 | 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 |
|---|---|
| K223388 | 2023-07-07 |
| K214112 | 2022-07-26 |
| K182191 | 2019-02-01 |
| K180415 | 2018-11-02 |
| K172145 | 2018-05-09 |
| K170088 | 2017-04-06 |
| K161128 | 2016-12-01 |
| K151261 | 2015-10-07 |
| K142626 | 2015-06-12 |
| K141926 | 2014-12-19 |
| K113678 | 2012-10-01 |
| K080357 | 2008-07-24 |
| K061435 | 2006-06-08 |
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 |
|---|---|---|---|---|---|
| 2019-12-02 | Class II | Packaging | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. | 331 | 2020-11-02 |
| 2018-02-07 | Class II | Device Design | Device may display a battery missing error. | 778 units | 2018-12-04 |
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.