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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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XENOVIEW Dose Delivery Bag - 00850045949013

The XENOVIEW™ Dose Delivery Bag is used to collect the dispensed XENOVIEW™ (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a clamp to secure XENOVIEW™ inside, and a mouthpiece for the patient to inhale the gas. XENOVIEW™ Dose Delivery Bags come packaged with 50 one-liter dose delivery bag assemblies, as well as 55 individual bag labels. The XENOVIEW™ Dose Delivery Bag is a single-dose disposable drug container, for use with the HPX Hyperpolarization System.
Polarean, Inc.
Rev B
In Commercial Distribution

  • 00850045949013 ()
44639-01

  • Lung MRI xenon hyperpolarization system delivery bag/mouthpiece

HPX Hyperpolarizer - 00850045949006

The HPX Hyperpolarizer is the device used to hyperpolarize the Xenon Xe 129 Gas Blend for the production of XENOVIEW™. It consists of a laser optical pumping system and a cryogenic xenon condenser system. With the use of the HPX Gas Handling Manifold, the Xenon Xe 129 Gas Blend is delivered to the HPX Hyperpolarizer where it undergoes spin exchange optical pumping (SEOP) process, which produces XENOVIEW™.
Polarean, Inc.
Rev E
In Commercial Distribution

  • 00850045949006 ()
49820

  • Lung MRI xenon hyperpolarization system

MedSource Face Mask - 00840155402645

Ear Loop Mask- Yellow
MEDSOURCE INTERNATIONAL LLC
MS-12126-Y
In Commercial Distribution

  • 00840155402652 ()
  • 00840155402645 ()
Not Applicable

  • Public face mask, reusable

MedSource Face Mask - 00840155402621

Ear Loop Mask- Blue
MEDSOURCE INTERNATIONAL LLC
MS-12126
In Commercial Distribution

  • 00840155402621 ()
  • 00840155402638 ()
Not Applicable

  • Public face mask, reusable

MedSource Face Mask - 00840155402584

FFP2 Mask
MEDSOURCE INTERNATIONAL LLC
MS-12122
In Commercial Distribution

  • 00840155402591 ()
  • 00840155402584 ()
Not Applicable

  • Public face mask, 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

Nano-CheckTM COVID-19 IgG/IgM Antibody Test - 00895160002663

A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8145
In Commercial Distribution

  • 10895160002660 ()
  • 00895160002663 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

First Aid Only - 00092265222662

Custom first aid kit with supplies for 10 people in a plastic case containing first aid items needed to help treat minor injuries
Acme United Corporation
222-U/NORTHERN
In Commercial Distribution

  • 00092265222662 ()
222-U/NORTHERN

  • First aid kit, medicated

First Aid Only - 00092265549455

Custom first aid kit with supplies for fifty people in a plastic case containing first aid items needed to help treat minor injuries.
Acme United Corporation
54945
In Commercial Distribution

  • 00092265549455 ()
54945

  • First aid kit, medicated

First Aid Only - 00092265910958

First aid kit in a plastic cabinet with SmartCompliance boxes. Kit designed for food industry and contains first aid supplies to treat minor injuries.
Acme United Corporation
91095
In Commercial Distribution

  • 00092265910958 ()
91095

  • First aid kit, medicated
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