What is FDA product code OMP?

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

General & Plastic Surgery › SurgicalNegative Pressure Wound Therapy Powered Suction Pump

Invia Fitpad

Name: Invia Fitpad
Brand: Invia Fitpad

Invia FitPad is the suction interface used with compatible Invia negative pressure wound therapy dressings. It connects the dressing arrangement to the canister tubing of an Invia Motion or…

Registry build 21.09.26

Invia FitPad is the suction interface used with compatible Invia negative pressure wound therapy dressings. It connects the dressing arrangement to the canister tubing of an Invia Motion or Invia Liberty therapy system.

The interface uses a quick connector to join the dressing to the canister tubing. In the assembled therapy system, this connection provides the fluid and pressure pathway between the wound dressing and the collection system.

Listed Item

Invia Fitpad sterile 10 PCs – 087.0028

Compatibility and Supply

FitPad is supplied sterile for a single use as a component of the Invia dressing arrangement. The dressing components are intended for use only with the compatible Invia Motion and Invia Liberty therapy units.

8manufacturers in China registered for this device type

1catalogue number

13510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code OMP
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

Regulatory record for Invia Fitpad
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)	K170088
Record published	2017-06-07
Record revised	2018-07-06 (version 3)

Specifications

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 numbers for Invia Fitpad
Catalogue number	Size	Status
200.7943		In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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 Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Invia Fitpad
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Medela LLC	510(k) number	2019-12-02	Class II	Packaging	Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.	331	2020-11-02

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.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
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.