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The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S00R4
In Commercial Distribution
- 00849405001607 ()
- Negative-pressure wound therapy system, electric, single-use
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-4
In Commercial Distribution
- 00849405000549 ()
- Negative-pressure wound therapy system, electric, single-use
MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as well as associated antimicrobial resistance genes, by the BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panel on FilmArray® systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenza, Neisseria meningitides, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-48-like, VIM, mcr-1. Control 2 - GPY: Gram positive bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunesis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatti; antimicrobial resistance genes: mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device.
STRECK, INC.
250065
In Commercial Distribution
- 00844509002338 ()
- Total Volume: 1.0 Milliliter
250065
- Multiple-type bloodstream pathogen nucleic acid IVD, control
Mains powered, Infrared phototherapy device emitting up to 15 W at 810 & 980 nm. The LightForce EX (LTS-1500) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
The EX is a portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTS-1500
In Commercial Distribution
- 00854103007028 ()
- Musculoskeletal infrared phototherapy unit, non-wearable
Infrared phototherapy device emitting up to 15 W at 980 & 810 nm. The device can be powered through its battery pack or mains power. The LightForce FX (LTC-1500) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting. relaxation of the muscle tissue and to temporarily increase local blood circulation.
The FX is a compact, portable, and mobile medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTC-1500
In Commercial Distribution
- 00854103007011 ()
- Musculoskeletal infrared phototherapy unit, non-wearable
WERAY is a battery-operated, portable dental X-ray source designed for handheld operation. It is intended to produce diagnostic-quality X-ray images. The WERAY is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow the WERAY to be used. Still, transportation or using other X-ray devices might be prohibitive due to the other devices’ size and/or lack of mobility. The WERAY is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), a Cone for the sensor, Acryl shielding, a cradle, a Hand switch for X-ray exposure, and an AC/DC adaptor. The power is supplied by a rechargeable Lithium-ion polymer battery pack built into a main body. This facilitates the portability of the device. A beam-limiting cone is incorporated within the device. The acryl shielding provides sufficient radiation
protection to allow the clinician to remain in the operatory with the patient. A hand switch is available to expose X-rays in a location away from the device. WERAY uses a fixed tube voltage of 70kV and a fixed tube current of 2.0 mA to make the system as simple as possible for the operator. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, a display panel, and an exposure button provide the primary operator interface. Exposure settings can be selected and displayed. The tube voltage (70 kV) and tube current (2.0 mA) are fixed, with the exposure time varying based on patient type, detector type, and anatomical features. Exposures can be completed using the exposure button. The WERAY should be used with an X-ray detector and a digital intraoral sensor. But the X-ray detector is not included in the device package.
PICOPACK Inc.
P70A
In Commercial Distribution
- 18809840720043 ()
- 08809840720046 ()
- 28809840720040 ()
- 38809840720047 ()
- 48809840720044 ()
- Depth: 106 Millimeter
- Height: 269 Millimeter
- Width: 302 Millimeter
- Hand-held intraoral dental x-ray system, digital
The Genadyne UNO+ NPWT (Ref # UP-S01) is a multi-patient use, rechargeable Negative Pressure Wound Therapy unit, designed for moderate to low severity wounds. The UNO+ NPWT features an interface panel which provides 5 alerts to the user, selectable therapy modes (continuous mode and variable mode) and multi pressure options (40mmHg, 60mmHg,80mmHg, 100mmHg or 125mmHg). The UNO+ NPWT is packaged in a box that includes a universal charger, USB cable, a user manual and a user carry bag. It will be made compatible with the dressing kits that was already approved under K143726. The dressing kits includes the transparent film dressings, a choice of wound filler (i.e. XLR8 green foam, Genadyne Hybrid Dressing) and the XLR8 Port Pad. The UNO+ NPWT is designed to be used with a canister collection system. The canister will have 2 sizes available (200cc and 300cc). Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes.
GENADYNE BIOTECHNOLOGIES INC.
UP-S01
In Commercial Distribution
- 00849405000495 ()
- Negative-pressure wound therapy system pump, electric
The Vivo 45 LS Ventilator is a portable, microprocessor-controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers. Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support. The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery. The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.
Breas Medical AB
US
In Commercial Distribution
- 07321822300004 ()
- 07321822300165 ()
- 07321822302169 ()
230000
- Portable electric ventilator
The CQ-29CN / D-11 TDP infrared therapy lamp contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating coil in the TDP lamp head, it begins to emit FIR (far infrared) waves which, along with the ionized minerals, easily penetrates deep into the body to be absorbed.
A digital control panel with a back-lit LCD screen is located on the stand. Get precise controls over different aspects of treatment. Set treatment duration with the built-in timer by pressing the Timing button—adjustable from 30-60 minutes in 5 minute increments. Power level is also adjustable by pressing Adjustment button to set power from 50-100% in 10% increments. The LCD display is large and clear giving you all the information you need at a glance.
The CQ-29CN lamp is a free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the telescoping main post and articulating neck, the emission head can be positioned as low as 21" to as high as 61" from the floor with the post fully extended. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.
A & A MEDICAL SUPPLIES INC.
CQ-29CN
In Commercial Distribution
- B465CQ29CN0 ()
- Weight: 25 Pound
- Width: 24 Inch
- Adjustable Min/Max Height: 33.5"/62" above floor
D-11
- Musculoskeletal infrared phototherapy unit, non-wearable
Mains powered, infrared and nail laser phototherapy device emitting up to 15 W at 810 & 980 nm and up to 25 W at 980 nm. At 810 & 980 nm, the LightForce EXP (LTS-1500P) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. At 980 nm, the EXP is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes, Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).
The EXP is a portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTS-1500P
In Commercial Distribution
- 00854103007035 ()
- Nail laser phototherapy unit
- Musculoskeletal infrared phototherapy unit, non-wearable