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The Vena MicroAngioscope™ System is indicated for the visualization and diagnosis of vascular disease within the peripheral and coronary vessels.

The Vena MicroAngioscope System consists of two main components: the Vena MicroAngioscope™ (MA) and the Vena Camera Control Unit (CCU).

The Vena MA is a full-color, forward-viewing, imaging angioscope intended to be used in conjunction with fluoroscopy to aid in vascular interventions. Designed to be used either with a parent catheter or balloon irrigation, it has a working length of 160 cm with a diameter of 3 French (0.040") at the distal tip and 2.7 French (0.036") at the proximal end. A radiopaque marker band is positioned at the distal tip of the device. The device features a lighting system surrounding a high-resolution video endoscope which provides real-time, high-resolution imaging inside blood vessels. This allows for direct, accurate visualization of vascular structures and pathologies, enabling precise interventions. The proximal end consists of a bifurcated joint for connection to an LED illumination source and a camera connector of the Vena CCU. This angioscope must be connected to the Vena CCU to acquire images and emit light. The Vena MicroAngioscope is the sterile, single use applied part of the Vena MicroAngioscope System.

The Vena CCU is a compact, reusable imaging processor designed to interface with the MA to provide power, process images, and output live video. Housed in a durable metal enclosure, the CCU features a front panel interface with a dedicated camera connector for enabling visualization and an LED connector for powering the integrated illumination system. The unit includes two control buttons: one for capturing still images and another for recording video. The CCU requires the Vena MicroAngioscope to be attached to the front connectors for operation. Real-time imaging is transmitted via an HDMI output, allowing seamless integration with external monitors, while a USB port enables image and video storage. To maintain sterility in the angiosuite, the CCU is designed to be fully draped during procedures. Additionally, the CCU can be grounded by connecting to the equipotential grounding pin. By providing high-quality image processing and intuitive controls, the Vena CCU enables enhanced visualization and procedural efficiency in vascular interventions.

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IPL 390nm-510nm Filter

• The treatment of inflammatory acne (acne vulgaris);
• The treatment of leukoderma, including vitiligo (acquired leukoderma).

IPL 400nm-1200nm Filter

• The treatment of moderate inflammatory acne vulgaris;
• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles);
• The treatment of benign cutaneous lesions including warts, scars and striae;
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins and venous malformations.
• Use on all skin types (Fitzpatrick I-VI).

IPL 515-1200nm Filter

• The treatment of moderate inflammatory acne (acne vulgaris).
• The treatment of tattoos and benign pigmented epidermal and benign cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and café-au-lait macules.
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair growth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regime.
• Use on all skin types (Fitzpatrick I-V).

IPL 540nm-1200nm Filter

• Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),
• Lentigines, nevi, and cafe-au-lait macules;
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• The treatment of benign cutaneous lesions including warts, scars and striae.
• The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair growth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regime.
• Use on all skin types (Fitzpatrick I-VI).

IPL 540nm-1200nm Filter

• Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),
• lentigines, nevi, and cafe-au-lait macules;
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• The treatment of benign cutaneous lesions including warts, scars and striae.
• The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair growth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regime.
• Use on all skin types (Fitzpatrick I-VI).

IPL 580nm-1200nm Filter

• The treatment of moderate inflammatory acne vulgaris.
• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
• The treatment of face and body benign vascular and benign pigmented lesions.
• The treatment of benign cutaneous lesions, including scars and striae.
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• The removal of unwanted hair to effect stable long-term or permanent hair reduction.. Permanent reduction in hair growth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months after the completion of a treatment regime.
• Use on all skin types (Fitzpatrick I-VI).

IPL 640nm-1200nm Filter

• The treatment of tattoos;
• The treatment of mild to moderate inflammatory and pustular inflammatory acne vulgaris;
• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait;
• The treatment of benign cutaneous lesions including warts, scars and striae;
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• Removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regimen).
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.

IPL 695nm-1200nm Filter

• Removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen).
• Use on all skin types (Fitzpatrick I-VI), including tanned skin

Intense IR Handpiece
Intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. It's also indicated for the treatment in the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

1064nm Long Pulse Handpiece

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime
• Treatment of pseudofolliculitis barbae (PFB)
• Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
• Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Café-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; verrucae, skin tags, keratoses, the removal of black, blue, or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos), plaques
• Benign cutaneous lesions, such as, but not limited to warts, scars, striae and psoriasis
• Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles, Perioral wrinkles
• Laser skin resurfacing procedures for the treatment of: Acne scars, wrinkles
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;

1064nm Long Pulse Handpiece - Short Pulse Operation

• Intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloidscars), and warts.
• Is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioralwrinkles.
• For use on all skin types (Fitzpatrick I-VI), including tanned skin.

1064nm Long Pulse Handpiece - Onychomycosis

• Podiatry (i.e. ablation, vaporization, incision, excision, and coagulation of soft tissue) including matrixectomy, radical nail excision, periungual and subungual warts, plantar warts, neuromas,
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).

Acroma Handpiece
The 1064 nm wavelength is indicated for:

• Treatment of benign vascular lesions such as (but not limited to): port wine stains; hemangiomas; warts; superficial and deep telangiectasias (venulectasias); reticular veins (0.1-4.0 mm diameter) of the leg; rosacea; venous lakes; leg veins; spider veins; Poikiloderma of Civatte; angiomas;
• Benign cutaneous lesions, such as, but not limited to: warts; scars; striae; psoriasis;
• Benign pigmented lesions such as, but not limited to: lentigos (age spots); solar lentigos (sun spots); cafe-au-lait macules; seborrheic keratoses; nevi and Nevus of Ota; chloasma; verrucae; skin tags; keratoses; the removal of black, blue or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos); plaques;
• Pigmented benign lesions to reduce lesions' size for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, including but not limited to: periocular wrinkles; perioral wrinkles;
• Laser skin resurfacing procedures for the treatment of acne scars; wrinkles,
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The 532 nm wavelength is indicated for:

• Incision, excision, ablation, vaporization of soft tissue;
• Tattoo removal: light blue, yellow, red; green;
• Benign vascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); angiomas (cherry, spider); telangiectasias; spider nevi;
• Benign pigmented lesions: cafe-au-lait macules; lentigines (senile and solar); freckles (ephelides); chloasma; nevi; nevus spillus; Nevus of Ota; Becker's Nevi;
• Other benign pigmented cutaneous lesions: verrucae; skin tags; keratoses; plaques

1540 GoSmooth Handpiece

• The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

2940 DualMode Handpiece
Dermatology and Plastic Surgery:

• Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins;
• Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars); Debulking benign tumors; Debulking cysts; Superficial skin lesions; Diagnostic biopsies; Decubitus ulcers;
• Podiatry
• Treatment of warts, plantar verrucae, large mosaic verrucae
• Matrixectomy

2940 DualMode Fractional

• Skin Resurfacing

1340nm ProDeep Handpiece

• Non-ablative laser handpiece is intended for use in skin resurfacing

ProDeep 6mm collimated handpiece:

• Treatment of fine lines and wrinkles, Treatment of atrophic acne scars, Treatment of mild to moderate inflammatory acne vulgaris

755nm Fiber Delivered Handpiece
755nm Handpiece (Zye and One)

• Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime; epidermal lesions (benign pigmented lesions) such as solar melanosis, hyperpigmentation, melasma, and ephelides, wrinkles, treatment of benign cutaneous lesions with vascular components including port wine stains, hemangiomas, facial and bodily telangiectasia, erythematous rosacea, angiomas and spider angiomas, poikiloderma of Civatte and superficial venous malformations.

1064nm Fiber Delivered Handpiece (Zye and One)

• In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of telangiectasia, superficial varicosities, angiomas and spider angiomas, hemangiomas, rosacea, and nevi. It is also designated for non-ablative treatment of facial wrinkles and for removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen); for the treatment of pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI), including tanned skin.
• In the DYNAMICS® mode, for temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).
• In the INTENSE® mode is intended for non-invasive Laser assisted lipolysis;"

HandPICO Handpiece
532nm (pico-second):

• Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange;
• Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

1064nm (pico-second):

• Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm (nano-second):

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
• Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III

1064nm (nano-second):

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-VI
• Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types I-VI

The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for:

• Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
• Treatment of acne scars in Fitzpatrick Skin Types II-V.
• Treatment of wrinkles in Fitzpatrick Skin Types I-IV.

The Zye Ultra is indicated for:
755 nm:
Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime; epidermal lesions (benign pigmented lesions) such as solar melanosis, hyperpigmentation, melasma, and ephelides, wrinkles, treatment of benign cutaneous lesions with vascular components including port wine stains, hemangiomas, facial and bodily telangiectasia, erythematous rosacea, angiomas and spider angiomas poikiloderma of Civatte and superficial venous malformations.

1064nm
In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of telangiectasia, superficial varicosities, angiomas and spider angiomas, hemangiomas, rosacea, and nevi. It is also designated for non-ablative treatment of facial wrinkles and for removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen); for the treatment of pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI), including tanned skin.

• In the DYNAMICS® mode, for temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).
• In the INTENSE® mode is intended for non-invasive Laser assisted lipolysis;"

The Vydence Family of Lasers consists of five models of configurable platforms that include up to nine different handpieces. The Vydence Family has multiple modalities including IPL and IR handpieces. In addition, there is a variety of different wavelength laser handpieces including 1064nm, 532nm, 1540nm, 2940nm, 1340nm and 755nm.

The Zye Ultra model has a feature that includes a blended mode which emits 755 nm Alex and 1064nm Nd:YAG laser energy sequentially

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Halcyon and Ethos radiotherapy system are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.

Halcyon and Ethos radiotherapy system with the HyperSight imaging feature produce kV CBCT anatomical images that can be used in the simulation and planning of radiation therapy.

Halcyon and Ethos Radiotherapy System are single energy medical linear accelerators (linacs) designed to deliver Image Guided Radiation Therapy and radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. They consist of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.

An electron gun generates electrons which are accelerated by radio frequency (RF) power from a magnetron. The electrons strike a tungsten target producing photons (X-rays) for treatment and MV Imaging. The photons produced by the target are monitored and controlled by a pressurized ion chamber.

A beam collimation subsystem consisting of a primary and secondary collimator and two stacked multileaf collimators (MLCs) shapes the photon beam to define the treatment area.

X-Ray images of the patient are used by the treater to verify the correct treatment location. MV Imaging uses the treatment beam and a flat panel imager whereas kV imaging uses a high-capacity kV X-ray tube, a kV collimation system with full fan bowtie filter with movable y-blades to define the imaging beam size and to capture the image, a kV imager.

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The VITAL Tubing Sets for Hemodialysis are sterile, single-use arterial and venous blood lines for exclusive use with AK98 (model BLU014E, BLU015E, BLU021E, BLU022E, BLU025E), Fresenius 2008 series (model BLU001E, BLU002E, BLU003E, BLU004E, BLU005E, BLU006E, BLU007E, BLU008E, BLU009E, BLU010E, BLU011E, BLU012E, BLU013E, BLU016E, BLU017E, BLU018E, BLU020E, BLU023E, BLU024E, BLU029E, BLU030E, BLU063E), Fresenius 5008X (model BLU026E, BLU027E) or Bbraun Dialog series Hemodialysis system (model BLU019E, BLU028E). The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

The VITAL Tubing Sets for Hemodialysis consists of an Arterial line and a Venous line. The tubing is soft, transparent, smooth and non-kink to ensure the good liquidity.

The proposed models have the same principles, intended use and manufacturing process, but have some difference in the product configuration and dimension. The typical/representative model is BLU063E among all the models due to it has the most complex structure for Ethylene Oxide sterilization which covers all the components of the other models and the distance from the closed end and ventilated end is the farthest.

The proposed devices are provided in sterile condition, it is subject to ethylene oxide sterilization prior to achieve a Sterility Assurance Level (SAL) of 10⁻⁶.

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The VyBrate-L™ VBR System is intended for use in the thoracolumbar spine (T1‐L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VyBrate-L™ VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems.

The VyBrate-C™ VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The VyBrate-C™ VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VyBrate-C™ VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Vy Spine™ VyBrate™ VBR System is comprised of implants components. The implant component, the VyBrate™ VBR device, is a spacer, which inserts between vertebral bodies in the anterior column of the thoracolumbar or cervical spine. The spacer is made of OXPEKK with Tantalum markers.

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The V-DAC Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral and neurovascular systems.

The V-DAC Catheter consists of 1) Distal Access Catheter and 2) Peel-Away Introducer Sheath.

The V-DAC Catheter is a single lumen, coil-reinforced, flexible, variable stiffness composite catheter. The catheter distal shaft has an external hydrophilic coating aimed at reducing friction during use. The distal end of the catheter shaft is radiopaque for fluoroscopic visualization, and the proximal end contains a luer hub that allows the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. Complete dimensions of the catheter are included on the device label.

The Peel-Away Introducer is an accessory provided with the catheter to aid in the delivery of the catheter.

The V-DAC Catheter and a Peel-Away Introducer are packaged together, they are provided sterile, non-pyrogenic, and are intended for single use only.

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IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for monitoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.

IDENTIFY uses surface guidance technology to monitor patient motion during radiotherapy treatment simulation and delivery. Its high precision SGRT cameras support:

• Positioning of the patient for treatment delivery
• Monitoring of the patient position during treatment delivery
• Respiratory motion management during simulation and treatment delivery

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The VaporShield™ is a sterile, single-use, closed system transfer device (CSTD), incorporating a preassembled Drug Vial holder (DVH) and Syringe (1mL, 22GA). The preassembled device is intended for medication draw from a drug vial only. After medication draw, the DVH is removed from the syringe, and the syringe is used for direct injection of hazardous and non-hazardous medication via subcutaneous or intramuscular administration. The syringe incorporates a safety mechanism which automatically retracts the needle inside the device for drug containment, and prevention of accidental needlesticks and device reuse. The VaporShield mechanically prevents drug transfer external to the device to minimize individual and environmental drug exposure. The VaporShield is intended for use by medical professionals who prepare/administer injection(s) to adults and adolescents in healthcare facilities. The device is not intended for neonates (<28 days old), infants (< 2 yrs old), or children (> 2 yrs. old – 12 yrs. old). The VaporShield Device is not intended for Compounding, Reconstitution, Phlebotomy, Intravenous injection, Intraperitoneal injection, or Intrathecal injection.

The VaporShield closed system transfer device (CSTD) is sterile, for single use, and is intended for direct injection of hazardous or nonhazardous drugs. A single configuration includes a 1 mL syringe, 22G cannula, and is pre-assembled with a Drug Vial Holder (DVH). Preassembly of the syringe and drug vial holder components are interlocked via a flex tab snap-fit connection. During drug draw, the DVH ensures a stable connection between the drug vial and syringe. The VaporShield has three (3) settings, two for needle length, and one (1) for safety. The DVH can be removed from the syringe when the syringe is placed in locked setting.

The VaporShield includes a safety mechanism that is manually activated by full plunger depression. When activated, the safety mechanism retracts the needle inside the plunger rod for containment, preventing accidental needlestick, and disallowing device reuse.

Syringe is intended for parenteral injection (subcutaneous / intramuscular).

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The Vektor Computational ECG Mapping System (vMap®) is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician.

vMap is a standalone Software as a Medical Device (SaMD) application. vMap receives electrocardiogram (ECG) data (from other FDA-authorized medical devices) acquired non-invasively from the patient's body surface and processes these signals using proprietary algorithms to transform body surface measurements into cardiac electrical data. vMap utilizes this data to generate 2D cardiac information and 3D color maps that illustrate cardiac electrical features for physician analysis. vMap is intended for use in clinical environments, including electrophysiology (EP) laboratories and hospital settings.

vMap includes a main user application that provides an intuitive user interface to guide clinicians through the mapping workflow. vMap enables users to:

a. Create and manage mapping cases through an organized case management system.
b. Upload ECG data acquired from compatible recording systems.
c. Identify arrhythmias to be mapped, including marking arrhythmic beats on ECG plots.
d. Generate two-dimensional (2D) and three-dimensional (3D) heatmaps representing likely arrhythmia source locations.
e. View and interact with mapping results within the software interface.
f. Export results for integration with external electroanatomic mapping systems (e.g., Carto™, Ensite™)
g. Produce detailed case reports summarizing the mapping session and findings.

vMap SaMD operates on compatible general-purpose computing hardware that includes an off-the-shelf processing unit, monitor, keyboard and mouse. The vMap software is compatible with equivalent hardware components.

Principles of Operation:

vMap receives electrocardiographic signals acquired non-invasively from the body surface. The ECG signals are used in proprietary algorithms to transform the measured body surface signals into cardiac signals. These algorithms leverage simulated focal or rotor activity from simulated source locations across the entire heart. vMap analyzes focal-based mechanisms for focal-type and anatomical reentry-type arrhythmias (Focal Atrial Tachycardia, Premature Atrial Complex, Atrial Pacing, Ventricular Tachycardia, Premature Ventricular Complex, Ventricular Pacing, and Atrioventricular Reentrant Tachycardia, Typical Atrial Flutter and Atypical Atrial Flutter), and rotor-based mechanisms for fibrillation-type arrhythmias (Atrial Fibrillation and Ventricular Fibrillation). vMap software utilizes this data to provide various 2D cardiac information and interactive 3D color maps, including cardiac electrical features, for analysis by a physician.

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