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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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UroShield Kit - 07290103420260

The UroShield device is a single-patient, extracorporeal accessory to indwelling urinary catheters consisting of a disposable Actuator and a reusable Driver. After the Foley catheter is placed in the patient, the disposable Actuator is clipped on the extracorporeal part of the catheter and then connected to the reusable Driver through the Actuator’s cable connector and Driver’s cable socket connection. When the Driver is turned on, the Actuator creates surface acoustic waves that propagate on the catheter surface. The UroShield surface acoustic waves reduce bacterial adhesion on the catheter surface, thereby designed to minimize the risk of CAUTI (Catheter-Associated Urinary Tract Infections).
NANOVIBRONIX INC.
3.0
In Commercial Distribution

  • 07290103420260 ()
10-200-0004

  • Urinary catheter ultrasonic bacterial adhesion inhibition system

UroShield Actuaor 10 pack - 07290103420123

A package of 10 x UroShield disposable Actuators The UroShield is a single catheter use accessory that is clipped on the catheter's external part. After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
NANOVIBRONIX INC.
3.0 Actuator
In Commercial Distribution

  • 07290103420123 ()
10-200-0002

  • Urinary catheter ultrasonic bacterial adhesion inhibition system actuator

UroShield Actuator - 07290103420116

The UroShield disposable Actuator is a single catheter use accessory that is clipped on the catheter's external part. After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
NANOVIBRONIX INC.
3.0 actuator
In Commercial Distribution

  • 07290103420116 ()
10-600-0003

  • Urinary catheter ultrasonic bacterial adhesion inhibition system actuator

Access SARS-CoV-2 IgG II QC - 15099590742768

The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69059
In Commercial Distribution

  • 15099590742768 ()
C69059

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Access SARS-CoV-2 IgG Calibrator - 15099590738655

The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58963
In Commercial Distribution

  • 15099590738655 ()
C58963

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Access SARS-CoV-2 IgM Calibrator - 15099590738624

The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgM calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58958
In Commercial Distribution

  • 15099590738624 ()
C58958

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator

WeCare - 00810084932094

KN95 Masks 20-Pack
Jeg & Sons Inc.
Dark Gray - Adults
In Commercial Distribution

  • 00810084939314 ()
  • 00810084932094 ()
WMN100142

  • Public respirator, single-use

MedSource Face Mask - 00816703025901

Face Mask, Padded, Adult, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21135
In Commercial Distribution

  • 00816703025901 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use

MedSource Face Mask - 00816703025895

Ventilation Mask Size 4
MEDSOURCE INTERNATIONAL LLC
MS-21134
In Commercial Distribution

  • 00816703025895 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use

MedSource Face Mask - 00816703025888

Face Mask, Padded, Toddler, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21133
In Commercial Distribution

  • 00816703025888 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
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