SEARCH RESULTS FOR: (*what is fsi pso billmatrix*)(9111 results)

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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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Medical Face Mask - 04007418891141

A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.
Hans Hepp GmbH & Co. KG
89114
In Commercial Distribution

  • 04007418891141 ()


  • Public face mask, single-use

Universal ZGO Densah Bur Holder - 00850017652781

Universal Densah Bur Holder is a holder for the ZGO Densah Burs and ZGO Guided Keys, ZGO Tapered Pilot Drill
VERSAH, LLC
ZBLK
In Commercial Distribution

  • 00850017652781 ()


  • Surgical instrument interim-placement holder, reusable

Redicare - B70901020760

First Aid Kit to aid in administering Cardiopulmonary Resuscitation (CPR) & reviving a patient who is not breathing. Managed First Aid.
REDICARE LLC
Resuscitation Kit
In Commercial Distribution

  • B70901020760 ()
0102076

  • Cardiopulmonary resuscitation kit, single-use

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

ZGO Guided Key for ZPLTT and ZT1525 - 00850017652767

ZGO C-Guide Sleeve is placed into ZGO surgical guide by the dental las as appropriate for each patient anatomy and treatment plan.
VERSAH, LLC
ZGK
In Commercial Distribution

  • 00850017652767 ()


  • Surgical instrument interim-placement holder, reusable

ZGO C-Guide Sleeve - 00850017652750

ZGO C-Guide Sleeve is placed into ZGO surgical guide by the dental las as appropriate for each patient anatomy and treatment plan.
VERSAH, LLC
ZCG
In Commercial Distribution

  • 00850017652750 ()


  • Surgical instrument interim-placement holder, reusable

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 - 15099590738648

The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. The Access SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58961
In Commercial Distribution

  • 15099590738648 ()
C58961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Access SARS-CoV-2 IgG QC - 15099590738662

The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58964
In Commercial Distribution

  • 15099590738662 ()
C58964

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

Access SARS-CoV-2 IgM QC - 15099590738631

The Access SARS-CoV-2 IgM QC is intended for monitoring system performance of the Access SARS-CoV-2 IgM assay. The Access SARS-CoV-2 IgM QC is for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgM QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58959
In Commercial Distribution

  • 15099590738631 ()
C58959

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