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Found 16 results
510(k) Data Aggregation
K Number
K243225Device Name
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
Manufacturer
Genadyne Biotechnologies, Inc.
Date Cleared
2024-12-31
(84 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
Genadyne Biotechnologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.
Device Description
The Nasal Pillow Mask is patient interface device intended for use with CPAP/VPAP therapy systems. The device provides non-invasive means of delivering positive airway pressure to the user by creating a sealed interface using nasal pillows that fit directly into the patients' nostrils. The Nasal Pillow Mask is made of silicone material and comes in 3 different sizes (S, M & L). The nasal mask comes with standard hose fitting intended to be used with standard CPAP/VPAP system. It is intended to be use on patients (> 30 kg) who have been prescribed CPAP/VPAP therapy at home, hospital, or institutional environments. The complete mask set incudes headgear, frame, tube, and nasal pillows (S, M, & L sizes).
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K Number
K233614Device Name
Genadyne DUO NPWT
Manufacturer
Genadyne Biotechnologies, Inc.
Date Cleared
2024-12-23
(406 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Genadyne Biotechnologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Genadyne DUO Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
· The Genadyne DUO NPWT System, in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. • Instillation therapy is indicated for patients who would benefit from vacuum assisted drainery of topical wound treatment solutions and suspensions over the wound bed.
The Genadyne DUO Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Device Description
The Genadyne DUO NPWT is a Negative Pressure Wound Therapy unit with instillation option. The DUO NPWT features an interface touch panel which provides user selectable therapy modes (continuous mode and variable mode) and multi pressure options from 40 m m H g to 200 mmHg). The DUO NPWT is packaged in a box that includes a universal charger, power cable, a user manual and a user carry bag. The dressing kits includes the transparent film dressings, the Genadyne foam dressing and the Genadyne Port. The DUO NPWT is designed to be used with a canister collection system. The canister will have 3 sizes available (600cc, 800cc and 1100cc). All the dressings and canisters are single use disposable items. To help ensure safe and effective use, the DUO NPWT are to be used only with the Genadyne supplied dressings and canisters. There is an instillation option on the device for instillation therapy for the patient that requires it. The installation option provides a controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The instill mode consists of NPWT combined with the automatic, controlled delivery and removal of wound treatment solutions to and from the wound bed. It offers a more conducive dressing environment for wound bed management with adjustable target pressure, vacuum time, instill volume, and soaking time. With the adjustable target pressure, negative pressure in mmHg is applied to the wound.
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K Number
K221888Device Name
Genadyne Hybrid Foam Dressings
Manufacturer
Genadyne Biotechnologies, Inc.
Date Cleared
2023-06-12
(348 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Genadyne Biotechnologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Genadyne Hybrid Foam Dressings when used in conjunction with the XLR8+, UNO30 and UNO Plus NPWT System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Device Description
The Genadyne Hybrid foam dressings are designed to be used with the Genadyne XLR8+ NPWT (K143726), UNO30 (K190028) and UNO Plus (K210107). The dressing has a layer of silicone that will be placed as a contact layer to the patients wound. All the dressings are single use disposable items. To help ensure safe and effective use, the Genadyne Hybrid foam dressings are to be used only with the Genadyne supplied devices. The decision to use clean versus sterile/aseptic technique for wound cleaning is dependent upon wound pathophysiology, physician/clinician preference, and institutional protocol.
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K Number
K210107Device Name
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Manufacturer
Genadyne Biotechnologies, Inc.
Date Cleared
2022-06-01
(502 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Genadyne Biotechnologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K180840Device Name
UNO Negative Pressure Wound Therapy System
Manufacturer
Genadyne Biotechnologies, Inc.
Date Cleared
2018-11-30
(245 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Genadyne Biotechnologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed surgical incision. Genadyne UNO is a single patient use device.
Device Description
The UNO Negative Pressure Wound Therapy System is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound.
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K Number
K161599Device Name
UNO Negative Pressure Wound Therapy System
Manufacturer
GENADYNE BIOTECHNOLOGIES, INC.
Date Cleared
2017-04-06
(301 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
GENADYNE BIOTECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material.
Appropriate wound types include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
Genadyne UNO is a single patient use device.
Device Description
The UNO Wound Vacuum System is portable, battery powered wound suction pump with the intention to apply negative pressure to the wound.
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K Number
K143726Device Name
XLR8 PLUS (XLR8+)
Manufacturer
GENADYNE BIOTECHNOLOGIES, INC.
Date Cleared
2015-06-19
(172 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
GENADYNE BIOTECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XLR8 Plus (XLR8+) Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
Device Description
The XLR8 Plus (XLR8+) Wound Vacuum System is a portable, rechargeable battery powered wound suction pump with the intention to generate negative pressure to remove exudate from the wound.
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K Number
K143574Device Name
Melodi Prime Breast Pump
Manufacturer
Genadyne Biotechnologies, Inc.
Date Cleared
2015-04-21
(125 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Genadyne Biotechnologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The powered Melodi Prime Breast Pump is intended to express and collect milk from the breast of a lactating woman. This device is a double pump with a single pumping option; it is intended for a single user.
Device Description
The Melodi Prime breast pump is a battery operated breast pump. It operates with 4 AA size batteries. It comes with a power adapter as it can be used with a power adapter without batteries as well. The power adapter does not charge the batteries.
The Melodi Prime breast pump is designed to be a single patient use device. It consists of a LCD display that allows the user to see the current settings of the device. It is an easy to use device, consist of 5 buttons (On/Off, + , - , Phase 1/ Phase 2, & Single/ Double Pumping).
The breast pump allows for single pumping and double pumping options. The suction hose connections are independent of each other. Inside the device, it consists of a PCB, motor and valve.
The accessories that comes with the device are from Ardo Medical AG. The PumpSets are approved under K141742.
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K Number
K141961Device Name
GENADYNE SPIRO FOAM DRESSING KIT
Manufacturer
GENADYNE BIOTECHNOLOGIES, INC.
Date Cleared
2015-03-26
(251 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
GENADYNE BIOTECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Genadyne Spiro Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K09063) to deliver negative pressure wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious materials and tissue debris.
Spiral Foam Dressing 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
Gendayne Spiro Foam Dressing Kit is a single-use dressing is housed in a Tyvek/Mylar Peel Pouch.
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K Number
K141437Device Name
XLR8 PLUS (XLR8+)
Manufacturer
GENADYNE BIOTECHNOLOGIES, INC.
Date Cleared
2014-09-19
(112 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
GENADYNE BIOTECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XLR8 Plus (XLR8+) Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
Device Description
The XLR8 Plus (XLR8+) Wound Vacuum System is portable, rechargeable battery powered wound suction pump with the intention to deliver negative pressure to the wound. The XLR8 Plus (XLR8 +) is a modification to the existing A4-XLR8 wound vacuum system with exactly the same internal components and accessories. The XLR8+ is a lightweight, portable wound suction device. It has a rechargeable battery, LCD screen for clear viewing, membrane overlay with buttons to control the device. It has 2 therapy options, continuous therapy and variable intermittent therapy. It consists of 5 alerts to notify the users of unwanted events, i.e. leakage in the dressing, blockage in the tubing, canister is full, low battery status.
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