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Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
BIO-MED DIAGNOSTICS, INC.
1293
In Commercial Distribution
- B08812934 ()
- B08812930 ()
- B08812932 ()
21-293-001
- Potato-dextrose fungal agar culture medium IVD
Electrode conductive pad
A small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation electrode and the skin.
It is typically contoured to fit on a particular type of electrode and is made of an absorbent material (e.g., felt)
that may be soaked in a conduction fluid.
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
TKF5050
In Commercial Distribution
- 04719871183489 ()
- Electrical probe/electrode conductive pad
This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.
Carl Zeiss Meditec AG
VISULAS YAG III
In Commercial Distribution
- 04049471091373 ()
- Laser console (H x W x D) 135mm x 210mm x 330mm
- Ophthalmic solid-state laser system, photodisruption
The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only.
STANBIO LABORATORY, L.P.
401010
In Commercial Distribution
- 00657498000090 ()
- 00657498001868 ()
401010
- Single-channel clinical chemistry analyser IVD, point-of-care
Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to enhance swallowing treatment by assisting with proper position of head and neck, maintaining placement and improving electrical conduction of E Series Electrodes and providing a resistive exercise protocol. For single patient use.
AMPCARE, LLC
RPD
In Commercial Distribution
- 00867786000231 ()
50707
- Cervicothoracic spine orthosis
HCG Control Set, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 mL.
Medtest Dx, Inc.
HCG-CTL
In Commercial Distribution
- 00817439020819 ()
HCG-CTL
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
Phosphate Buffered Saline (PBS), 1.0ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20
Hardy Diagnostics Phosphate Buffered Saline (pH of 7.5) is recommended as a diluent for quantitative culturing or as a rinsing agent in microbiological, immunological, histological and molecular testing procedures.
HARDY DIAGNOSTICS
R201
In Commercial Distribution
- 00819398023184 ()
- 00819398023191 ()
R201
- Buffered sample diluent IVD, manual
The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body.
The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients.
The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation).
The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician.
INTELESENS LIMITED
PN1287
In Commercial Distribution
- 15060484630089 ()
- 05060484630082 ()
- Electrocardiography telemetric monitoring system
The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body.
The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients.
The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation).
The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician.
INTELESENS LIMITED
PN0620
In Commercial Distribution
- 15060484630003 ()
- 05060484630006 ()
- Electrocardiography telemetric monitoring system
The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario
USB-C meter is connected to a SMD through a USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display for
the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006390)
The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178)
LABSTYLE INNOVATION LTD
1200-05
In Commercial Distribution
- 00850065006406 ()
- Glucose IVD, kit, enzyme spectrophotometry, rapid
- Glucose monitoring system IVD, home-use