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A sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.
INDILAB INC.
IND400S
Not in Commercial Distribution
- 00860000763615 ()
- 00860000763608 ()
- Length: 4 Inch
IND400S
- Chemical/physical sterilization process indicator
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution
- 00860000709408 ()
- Depth: 73 Millimeter
- Width: 113 Millimeter
- Height: 40 Millimeter
- Cognitive assessment software
Device Description:
The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics
and home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device.
The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a
Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops
including inspiratory and expiratory data. The internal program performs all of the calculations for
measurements to meet American Thoracic Society and European Respiratory Society requirements. It has
built-in quality control measurements and transmits indices of measurement quality including time to peak
flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.
It is used with the GoSpiro App display and communications software on a smartphone or tablet.
The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging
station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC
60601-1-11.
The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer
measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus
avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the
device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This
transducer is insensitive to the effects of condensation and temperature and avoids the need for individual
calibration prior to performing a test.
Indications for Use:
The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics
and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.
MONITORED THERAPEUTICS, INC.
45-90058
In Commercial Distribution
- 00860000692809 ()
45-90058
- Diagnostic spirometer, professional
The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array.
Hyperfine Operations, Inc.
V2.0 (815-11016-04)
In Commercial Distribution
- 00860000606158 ()
- MRI system coil, radio-frequency
Modern Fertility Ovulation Test 20ct
MODERN HEALTH
A
Not in Commercial Distribution
- 00860000599627 ()
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution
- 00860000564052 ()
- Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution
- 00860000564045 ()
- Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution
- 00860000564038 ()
- Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution
- 00860000564021 ()
- Cognitive assessment software
No Description
COGNIVUE, INC.
Desktop Unit
In Commercial Distribution
- 00860000564014 ()
- Cognitive assessment software
No Description
COGNIVUE, INC.
Cart Unit
In Commercial Distribution
- 00860000564007 ()
- Cognitive assessment software
No Description
Sealcath, LLC
0006560
In Commercial Distribution
- 10860000559130 ()
- 00860000559133 ()
- Catheter Gauge: 30 French
- Barium enema catheter
- Enema tip, single-use
No Description
Sealcath, LLC
0006560
In Commercial Distribution
- 10860000559123 ()
- 00860000559126 ()
- Catheter Gauge: 20 French
- Enema tip, single-use
- Barium enema catheter
No Description
Sealcath, LLC
0006560
In Commercial Distribution
- 10860000559116 ()
- 00860000559119 ()
- Catheter Gauge: 30 French
- Barium enema catheter
- Enema tip, single-use
No Description
Sealcath, LLC
0006560
In Commercial Distribution
- 10860000559109 ()
- 00860000559102 ()
- Catheter Gauge: 20 French
- Barium enema catheter
- Enema tip, single-use
Softband 5, Bilateral XS/S Light Brown
Oticon Medical AB
227704
In Commercial Distribution
- 05712149026746 ()
227704
- Head-worn bone-conduction hearing aid holder, reusable
Softband 5, Bilateral XS/S Dark Brown
Oticon Medical AB
227703
In Commercial Distribution
- 05712149026739 ()
227703
- Head-worn bone-conduction hearing aid holder, reusable
Softband 5, Bilateral XS/S Black
Oticon Medical AB
227702
In Commercial Distribution
- 05712149026722 ()
227702
- Head-worn bone-conduction hearing aid holder, reusable
Softband 5, Bilateral M/L Beige
Oticon Medical AB
227701
In Commercial Distribution
- 05712149026715 ()
227701
- Head-worn bone-conduction hearing aid holder, reusable
Softband 5, Bilateral M/L Light Brown
Oticon Medical AB
227700
In Commercial Distribution
- 05712149026708 ()
227700
- Head-worn bone-conduction hearing aid holder, reusable