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The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electronically record adult male patient voiding data to assist in the diagnosis of lower urinary tract disorders and is designed for home use.
Stream Dx will calculate a patient's flow rate and their maximum voided volume based on the collected data. This information will be provided to the caregiver by Stream Dx.
The data obtained from the Stream Dx Uroflowmeter is meant to be used exclusively as a tool to aid in diagnosis of a condition. It is not intended to be used alone as the sole method of diagnosis.
ZIEN MEDICAL TECHNOLOGIES, INC.
SDX01
In Commercial Distribution
- 00860412001503 ()
SDX01
- Urine flowmeter, reusable
Total Cholesterol Strips
KPI HEALTHCARE, INC.
CURO L5 Total Cholesterol Strips
In Commercial Distribution
- 00860394001256 ()
- 00860394001218 ()
- Glucose/ketone/lipid monitoring system IVD, home-use
- Multiple physiological parameter spot-check system analyser
- Glucose monitoring system IVD, point-of-care
- Glucose analyser IVD, point-of-care
- Glucose analyser IVD, laboratory, automated/semi-automated
- Glucose analyser IVD, laboratory, manual
- Glucose analyser IVD, laboratory, automated
- Glucose analyser IVD, home-use
- Blood glucose/blood pressure monitoring system, point-of-care
- Glucose monitoring system IVD, home-use
- Blood glucose/blood pressure monitoring system, home-use
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
CURO L5 Cholesterol and Glucose measuring system
KPI HEALTHCARE, INC.
CURO L5 CURO L5
In Commercial Distribution
- 00860394001225 ()
- Multiple physiological parameter spot-check system analyser
- Glucose/ketone/lipid monitoring system IVD, home-use
- Glucose monitoring system IVD, point-of-care
- Glucose analyser IVD, point-of-care
- Glucose analyser IVD, laboratory, automated/semi-automated
- Glucose analyser IVD, laboratory, manual
- Glucose analyser IVD, laboratory, automated
- Glucose analyser IVD, home-use
- Blood glucose/blood pressure monitoring system, point-of-care
- Glucose monitoring system IVD, home-use
- Blood glucose/blood pressure monitoring system, home-use
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Surgical implant to reduce and stabilize the acromioclavicular joint.
CORACOID SOLUTIONS LLC
FG3007
In Commercial Distribution
- 00860366001420 ()
- Acromioclavicular joint stabilization implant
The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlined surgical technique.
CORACOID SOLUTIONS LLC
FG3004
In Commercial Distribution
- 00860366001413 ()
- Acromioclavicular joint stabilization implant
The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury.
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.
The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.5.0.7
In Commercial Distribution
- 00860334002121 ()
- Psychological assessment software
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.
The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.5
In Commercial Distribution
- 00860334002114 ()
- Psychological assessment software
The ANAM Test System: Military Battery (ANAM Military Battery) is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The ANAM Military Battery provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.
The ANAM Military Battery provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test results to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Military Battery will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.3
In Commercial Distribution
- 00860334002107 ()
- Psychological assessment software
No Description
XORAN TECHNOLOGIES LLC
11020
In Commercial Distribution
- 00860290000360 ()
- Cone beam computed tomography system, head/neck
No Description
XORAN TECHNOLOGIES LLC
10020
In Commercial Distribution
- 00860290000353 ()
- Cone beam computed tomography system, head/neck