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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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Arctic Sun® Temperature Management System, Upgrade (v 2.0.1)
Medivance, Inc.
76500
In Commercial Distribution

  • 00801741127809 ()
76500

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
DLW, PINCH TO INTELLIVUE COMPATIBLE, 5 LEAD, V LEAD
APK Technology Co.,Ltd.
I-DLP-05BV-40AS-0100
In Commercial Distribution

  • 16946725503147 ()
  • 06946725503140 ()


  • Electrocardiographic lead set, single-use
DLW, SNAP TO INTELLIVUE COMPATIBLE, 5 LEAD, V LEAD
APK Technology Co.,Ltd.
I-DLP-05AV-40AS-0100
In Commercial Distribution

  • 16946725503130 ()
  • 06946725503133 ()


  • Electrocardiographic lead set, single-use
M10130 - Shigella flexneri Monovalent Typing Antiserum - Type V - 2ml
MAST GROUP LIMITED
M10130
In Commercial Distribution

  • 15060392376376 ()
M10130

  • Shigella flexneri culture isolate antigen IVD, kit, agglutination
VACU-AIDE COMPACT Spencer, no power supply, 12 V Cord
DEVILBISS HEALTHCARE LLC
7310PD-S
Not in Commercial Distribution

  • 00885304000549 ()
7310PD-S

  • Airway suction catheter
INLET 21029 V A D 12MM W/BOTTOM INLET
MEDTRONIC PS MEDICAL, INC.
21029
In Commercial Distribution

  • 00763000028121 ()


  • Cranial port/reservoir
MAJOR PLUS V , SIX ARTIFICIAL TEETH, UPPER, SHADE A1, MOULD B6MAJOR PLUS V , SIX ARTIFICIAL TEETH, UPPER, SHADE A3, MOULD 25
MAJOR PRODOTTI DENTARI SPA
Shade A3, Mould 25
In Commercial Distribution

  • 08056640009608 ()
T2011

  • Resin artificial teeth
AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, Bag Reservoir, Mask, PEEP Valve, additional B/V Filter, and 100 mm Airway
VENTLAB, LLC
AF5140MBPF-G10
In Commercial Distribution

  • 30889483275751 ()
  • 10889483275757 ()
AF5140MBPF-G10

  • Pulmonary resuscitator, manual, single-use
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
20-006-001
Not in Commercial Distribution

  • 00857573006027 ()


  • Multiple coagulation factor IVD, kit, clotting
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
30-001-001
Not in Commercial Distribution

  • 00857573006348 ()


  • Multiple coagulation factor IVD, kit, clotting
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