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The CarePath system facilitates evaluations measuring urine output. It consists of
the CarePath device, accompanying documents, and training. The system:
• Measures and calculates flow rate and volume from urination data
• Automatically transmits urination data to a secure location
• Creates and provides uroflow reports to healthcare providers
The intended operator of the CarePath device is the patient. The CarePath
system has no user-serviceable components. This system is not to be serviced
or maintained by the user. The intended environments are hospitals, clinics,
doctor’s offices and the patient’s home.
I/O Urology Corp.
DCDUFD-001M
In Commercial Distribution
- 00860010862209 ()
- Urine flowmeter, reusable
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display.
The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.
The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV350
In Commercial Distribution
- 00860008259233 ()
- Electrocardiography telemetric monitoring system
The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil.
PATHY MEDICAL, LLC
PM-LJ100
In Commercial Distribution
- 00860000230704 ()
- 00860000230711 ()
- Operating room light
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 3-Sphere
Cardio Flow, Inc.
H6004
In Commercial Distribution
- 00850040691085 ()
- 00850040691108 ()
- Atherectomy Rotating Component Diameter: 1.5 Millimeter
- Mechanical atherectomy system catheter, peripheral
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-sphere
Cardio Flow, Inc.
H6002
In Commercial Distribution
- 00850040691054 ()
- 90850040691064 ()
- Atherectomy Rotating Component Diameter: 2.0 Millimeter
- Mechanical atherectomy system catheter, peripheral
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 5-sphere
Cardio Flow, Inc.
H6001
In Commercial Distribution
- 00850040691030 ()
- 90850040691040 ()
- Atherectomy Rotating Component Diameter: 1.5 Millimeter
- Mechanical atherectomy system catheter, peripheral
Cardio Flow Peripheral Guide Wire Guidewire, 325 CM
Cardio Flow, Inc.
GW1001
In Commercial Distribution
- 00850040691023 ()
- 00850040691009 ()
- 00850040691016 ()
- Guidewire Length: 325 Centimeter
- Peripheral vascular guidewire, manual
The CryoLab® Aesthetic device uses CryoConcepts’ design and technology to deliver a spray of Carbon Dioxide gas to treat topical cutaneous lesions. The intended use for the CryoLab® Aesthetics, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include skin tags, actinic keratosis, and seborrheic keratosis.
CRYOCONCEPTS, LP
700-1000
In Commercial Distribution
- 00850077006074 ()
700-1000
- Cryogenic spray, cutaneous
The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The intended use for the CryoLab®, for both gases, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include molluscum contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis.
CRYOCONCEPTS, LP
200-1000
In Commercial Distribution
- 00850077006067 ()
200-1000
- Cryogenic spray, cutaneous
Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).
Configuration: D310-G-1-23R-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution
- 00850594007998 ()
- Electroretinograph