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K Number
K100823Device Name
WOUND PRO APEX
Manufacturer
ACCURO MEDICAL PRODUCTS LLC
Date Cleared
2011-01-24
(306 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
ACCURO MEDICAL PRODUCTS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WoundPro Apex Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro Apex is intended for use in a healthcare facility only.
Types of Wounds Indicated are:
- Diabetic/Neuropathic ulcers
- Pressure ulcers
- Chronic wounds
- Acute wounds
- Dehisced wounds
Device Description
The Apex is part of the Wound Pro family of products offered by Accuro Medical Products LLC.
The Apex is a powered suction pump that uses controlled negative pressure. The control unit incorporates a maintenance free brushless DC motor and is powered by a rechargeable battery power source. Optionally the unit can be connected to mains power using the included Medical Grade Switching power converter.
Apex has a negative pressure setting range of 20mm to 150mmHg which is electronically monitored and controlled. The pump includes push button user interface controls and an electronic display with audible and visual alarm indicators.
The device can accommodate 300cc and 800cc canister sizes.
The unit can be operated on a countertop and has provisions for connection to IV poles, bed side rails, or footboard mounting.
The unit may be sold individually or as part of a system includes the following items:
- 1 Apex NPWT Pump
- 1 Mounting Clamp for IV Pole, Bedrail, or Footboard mounting
- 1 Hospital grade Charging Connection to 110V power source
- 1 Medium (flat drain) dressing kit. Kit includes:
- Non-adherent contact layer
- Anti-bacterial Gauze
- Drain Tube
- Drain Clamp
- Cover Dressing
- Instructions for use
- 1 Disposable 300cc Canister
- 1 Canister Tubing Set. Set includes:
- Dual lumen Tubing (runs between the canister and the connector)
- Clamp
- Connector for attachment to dual lumen tube to the drain
- Carrying Case
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