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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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TriOx™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated
ICU MEDICAL, INC.
50472
In Commercial Distribution

  • 10840619030084 ()
  • 00840619030087 ()
50472-01

  • Pulmonary artery balloon catheter, oximetric
The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.
ARK DIAGNOSTICS INC
5054-0001-01
In Commercial Distribution

  • 00812101030257 ()
5054-0001-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The ARK™ UR-144/JWH-018 Assay is an immunoassay intended for the qualitative determination of UR-144/JWH-018 and their metabolites in human urine at a cutoff concentration of 10 ng/mL.
ARK DIAGNOSTICS INC
5054-0001-00
In Commercial Distribution

  • 00812101030240 ()
5054-0001-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Mothership Wireless Fetal Transducer Base Station
TENACORE HOLDINGS, INC.
F1
In Commercial Distribution

  • 00852189007376 ()


  • Cardiotocography telemetric monitoring system receiver
No Description
Merit Medical Systems, Inc.
00884450031988
In Commercial Distribution

  • 10884450031985 ()
  • 00884450031988 ()
  • 20884450031982 ()

  • Gauge-20G
  • Accepts Guide Wire-0.025" (0.64 mm)
  • Length (cm)-4.0 cm


  • Anaesthesia conduction catheter holder, sterile
No Description
Merit Medical Systems, Inc.
00884450031971
In Commercial Distribution

  • 10884450031978 ()
  • 00884450031971 ()
  • 20884450031975 ()

  • Length (cm)-7.0 cm
  • Gauge-19G
  • Accepts Guide Wire-0.035" (0.89 mm)


  • Anaesthesia conduction catheter holder, sterile
No Description
Merit Medical Systems, Inc.
00884450031896
In Commercial Distribution

  • 10884450031893 ()
  • 00884450031896 ()
  • 20884450031890 ()

  • Accepts Guide Wire-0.018" (0.46 mm)
  • Gauge-22G
  • Length (cm)-6.0 cm


  • Anaesthesia conduction catheter holder, sterile
No Description
Merit Medical Systems, Inc.
00884450031803
In Commercial Distribution

  • 10884450031800 ()
  • 00884450031803 ()
  • 20884450031807 ()

  • Accepts Guide Wire-0.025" (0.64 mm)
  • Gauge-20G
  • Length (cm)-7.0 cm


  • Anaesthesia conduction catheter holder, sterile
No Description
Merit Medical Systems, Inc.
00884450031742
In Commercial Distribution

  • 10884450031749 ()
  • 00884450031742 ()
  • 20884450031746 ()

  • Gauge-18G
  • Accepts Guide Wire-0.038" (0.97 mm)
  • Length (cm)-7.0 cm


  • Anaesthesia conduction catheter holder, sterile
No Description
Merit Medical Systems, Inc.
00884450027837
In Commercial Distribution

  • 10884450027834 ()
  • 00884450027837 ()
  • 20884450027831 ()

  • Size (Volume)-10 mL


  • Anaesthesia conduction catheter holder, sterile
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