Invia Integrated Dressing
The Invia Integrated Dressing is used with compatible Invia negative pressure wound therapy pumps to remove wound fluid and manage open wounds or draining closed surgical incisions.…
The Invia Integrated Dressing is used with compatible Invia negative pressure wound therapy pumps to remove wound fluid and manage open wounds or draining closed surgical incisions. Applications include acute, chronic and traumatic wounds, ulcers, partial thickness burns, flaps and grafts.
A pad distributes negative pressure across the dressing and draws away exudate. A perforated silicone adhesive layer contacts the wound and surrounding skin, while double lumen tubing with a quick connector links the dressing to the pump.
Listed Item
Invia Integrated Dressing → Medium (10 X 15)
Compatibility and Depth
The sterile dressing connects to Invia Liberty, Motion or Ease pumps. Wounds deeper than 0.5 cm are likely to require additional wound filler to reach all wound surfaces; compatible Invia Black Foam can be used for this purpose.
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) | K223388 |
| Record published | 2023-07-20 |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 101035699 | 10 | In distribution | |
| 101035698 | 10 | In distribution | |
| 101035697 | 10 | 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.