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No Description
Remote Patient Devices LLC
RPD-3520G
In Commercial Distribution
- 00860004687535 ()
- Blood glucose/blood pressure monitoring system, home-use
No Description
Remote Patient Devices LLC
RPD-3250
In Commercial Distribution
- 00860004687528 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
The PAVmed CarpX is a sterile, single-use, bipolar high frequency electrosurgical device designed to direct radiofrequency energy from an electrosurgical generator into target tissue during minimally invasive or general surgical procedures for tissue cutting, including the isolation and division of ligaments, tendons and fascia such as the transverse carpal ligament for the treatment of carpal tunnel syndrome.
PAVMED INC.
260-03506
In Commercial Distribution
- 00860004588009 ()
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
CBCT upper & lower extremities including the pelvis
CURVEBEAM, LLC
1040-230
In Commercial Distribution
- 00860004550037 ()
- Limited-view-field CT system
CBCT upper & lower extremities including the pelvis
CURVEBEAM, LLC
1040-115
In Commercial Distribution
- 00860004550020 ()
- Limited-view-field CT system
ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.
Sibel Health Inc.
810-00013
In Commercial Distribution
- 00860004541752 ()
- Pulse oximeter
- Wearable multiple vital physiological parameter monitor
The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Sibel Health Inc.
810-00012
In Commercial Distribution
- 00860004541745 ()
- Wearable multiple vital physiological parameter monitor
ANNE Pediatric is a wireless vital signs monitoring platform for use on neonatal patients of any gestational age up to infants 2 years of age.
Sibel Health Inc.
SA-011
In Commercial Distribution
- 00860004541721 ()
- Wearable multiple physiological parameter recorder, reusable
ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the diagnosis of sleep-related breathing disorders by healthcare professionals.
Sibel Health Inc.
SA-008
In Commercial Distribution
- 00860004541714 ()
- Wearable multiple physiological parameter recorder, reusable
ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements.
Sibel Health Inc.
SA-002
In Commercial Distribution
- 00860004541707 ()
- Wearable multiple physiological parameter recorder, reusable