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510(k) Data Aggregation
K Number
K150459Device Name
FloSure Ventilation Patch
Manufacturer
SIMEX MEDIZINTECHNIK GmbH
Date Cleared
2016-01-05
(316 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
SIMEX MEDIZINTECHNIK GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FloSure Ventilation Patch is intended to be used in conjunction with NPWT Dressing Kits compatible with the SIMEX NPWT Systems EX200 and EX300 for the application of negative pressure wound therapy to the wound. The FloSure Ventilation Patch is to be applied to the occlusive wound dressing. When used in conjunction with the Simex NPWT EX200 and EX300 pumps and dressing kits, the FloSure Ventilation Patch is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of wound exudates, infectious material and tissue debris.
The FloSure Ventilation Patch is appropriate for use on the following wounds:
- · Pressure Ulcers
- · Diabetic/Neuropathic Ulcers
- · Venous Insufficiency Ulcers
- · Traumatic Wounds
- · Post-Operative and Dehisced Surgical Wounds
- · Skin Flap and Grafts
Device Description
The FloSure Ventilation Patch is used with the NPWT wound dressings to improve air-flow through the dressing when desired. The FloSure Ventilation Patch augments the transparent dressing by providing additional gas permeability to the wound dressing site through its proprietary hydrophobic and micro-porous filter membrane. The access to additional air-flow can aid in keeping the vacuum in balance resulting in a continuous flow of exudate. Stagnation in the flow of exudate can cause pooling at the wound site and result in blockage alarms.
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K Number
K141255Device Name
SIMEX SUBGLOTTIC ASPIRATION SYSTEM
Manufacturer
SIMEX MEDIZINTECHNIK GMBH
Date Cleared
2014-09-22
(131 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
SIMEX MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside.
Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal or tracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks.
Device Description
The SIMEX Subglottic Aspiration System models cuff S are lightweight portable or stationary suction/aspiration pumps for medical suction procedures where secretions, blood and other body fluids must be removed. The SIMEX cuff M and cuff S are designed for the application of intermittent aspiration of fluids which is particularly useful in the aspiration of subglottic secretions. Applications range from hospital, emergency care, and acute care facilities.
These pumps are designed and engineered for the proper and effective aspiration of subglottic secretion via intermittent suction. The pump can be set to operate (aspirate) anywhere from 1-60 seconds and to pause from 1-60 minutes. The factory setting is 10 seconds of aspiration time and 10 minutes of pause time and pressure of 100 mbar vacuum. SIMEX cuff M and cuff S suction pumps remove oral and/or gastric secretions from above the tracheal and or endotracheal tube cuff before they can be aspirated by the patient, using intermittent suction to remove subglottic secretions.
There are two models of the SIMEX Subglottic Aspiration System, Models cuff M and cuff S. The two models differ in their housing and collection canister configuration. Both models have the same overall system operation and software. The moving and electrical components of both models are housed in a molded, compact plastic housing. The units include attachment for an external power supply and/or a battery charger.
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K Number
K113291Device Name
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300
Manufacturer
SIMEX MEDIZINTECHNIK GMBH
Date Cleared
2012-08-30
(296 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
SIMEX MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIMEX Negative Pressure Wound Therapy System is indicated for patients that would benefit from a suction device particularly as the device may promote wound healing by removal of wound exudate, debris, and infectious material or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the patient's airway or respiratory support system. The SIM EX200 and SIM EX300 Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside.
Device Description
The SIMEX Negative Pressure Wound Therapy Powered Suction Pumps Series: SIM EX200 and SIM EX300 are lightweight, self contained, portable battery powered (or line powered), suction pumps for medical procedures where secretions and other body fluids and infectious materials must be removed through the application of continuous or intermittent negative pressure. The pumps are operated through computer software, having help and alarm features. The device is indicted for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The pumps may be used at patient's bedside. SIM EX200 and SIM EX300 are suitable for use in either hospitals or long term care facilities and nursing homes.
The SIMEX Negative Pressure Wound Therapy Powered Suction Pumps series is provided in two models, the SIM EX200 and the SIM EX300. Both pumps are powered with rechargeable lithium batteries and include ports for an external power supply and/or battery charger. The pumps can also be externally powered from a 12V automotive battery source. The SIMEX pumps vary in weight from 2.9lbs and in size from 90mm x 165mm x 220mm x 359mm x 250mm. The SIMEX pumps can be programmed to operate in either continuous or intermittent settings.
The disposable and replacement parts of the SIMEX Negative Pressure Wound Therapy series of pumps include collection canisters, canister liners, pump filters, hoses, connectors and drains (tubing), gauze dressings, and transparent film and drape dressings.
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