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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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CDI OneView™ Calibrator
Terumo Cardiovascular Systems Corporation
CDI740
In Commercial Distribution

  • 00886799001905 ()
CDI740

  • Extracorporeal blood gas/pH monitor
CDI OneView™ BPM Probe
Terumo Cardiovascular Systems Corporation
CDI753
In Commercial Distribution

  • 00886799001899 ()
CDI753

  • Extracorporeal blood gas/pH monitor
CDI OneView™ H/S Probe
Terumo Cardiovascular Systems Corporation
CDI754
In Commercial Distribution

  • 00886799001882 ()
CDI754

  • Extracorporeal blood gas/pH monitor
Monitor with one blood parameter module and one H/S Probe.
Terumo Cardiovascular Systems Corporation
550AHCT
In Commercial Distribution

  • 00886799001790 ()
550AHCT

  • Extracorporeal blood gas/pH monitor
Monitor with two blood parameter modules and one H/S Probe.
Terumo Cardiovascular Systems Corporation
550AVHCT
In Commercial Distribution

  • 00886799001783 ()
550AVHCT

  • Extracorporeal blood gas/pH monitor
Interface cable for Jostra HL 20
Terumo Cardiovascular Systems Corporation
158828
In Commercial Distribution

  • 00886799001738 ()
158828

  • Cardiopulmonary bypass system mounting unit
Monitor with two blood parameter modules.
Terumo Cardiovascular Systems Corporation
500AV
In Commercial Distribution

  • 00886799001639 ()
500AV

  • Extracorporeal blood gas/pH monitor
No Description
Maquet Cardiopulmonary AG
BMU 40 Cell 1/2"
Not in Commercial Distribution

  • 04037691349190 ()
  • 04037691349251 ()

  • Length: 102.7 Millimeter
  • Outer Diameter: 0.5 Inch
70104.0804

  • Cardiopulmonary bypass system blood gas sensor
R170 - The PDT Montana Explorer™ is the perfect companion for the Montana Jack, featuring the same contra-angle providing better universal adaptation.
PDT, INC.
R170 Montana Explorer
In Commercial Distribution

  • 00813677021151 ()
R170

  • Dental surgical probe, reusable
HPLC Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38910
In Commercial Distribution

  • 04250317523822 ()

  • 1 pcs.
38910

  • High performance liquid chromatography analyser column IVD
Trap Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38920
In Commercial Distribution

  • 04250317523761 ()

  • 1 pcs.
38920

  • High performance liquid chromatography analyser column IVD
No Description
Roche Diagnostics GmbH
08105383190
In Commercial Distribution

  • 07613336133514 ()
08105383190

  • Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08058601190
Not in Commercial Distribution

  • 07613336121474 ()
08058601190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08058580190
In Commercial Distribution

  • 07613336121467 ()
08058580190

  • Phenobarbital IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08057613190
In Commercial Distribution

  • 07613336121214 ()
08057613190

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
09230815190
In Commercial Distribution

  • 07613336224823 ()
09230815190

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
09230785190
In Commercial Distribution

  • 07613336224816 ()
09230785190

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08814708190
In Commercial Distribution

  • 07613336166109 ()
08814708190

  • Methaqualone IVD, reagent
No Description
Roche Diagnostics GmbH
08445567190
In Commercial Distribution

  • 07613336157787 ()
08445567190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08253161190
In Commercial Distribution

  • 07613336147948 ()
08253161190

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08253153190
In Commercial Distribution

  • 07613336147931 ()
08253153190

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08252670190
In Commercial Distribution

  • 07613336147917 ()
08252670190

  • Quinidine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08252661190
In Commercial Distribution

  • 07613336147900 ()
08252661190

  • Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08252637190
In Commercial Distribution

  • 07613336147870 ()
08252637190

  • N-acetylprocainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
3531066190
Not in Commercial Distribution

  • 04015630997169 ()
3531066190

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
3516989190
Not in Commercial Distribution

  • 04015630997138 ()
3516989190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
3510620190
Not in Commercial Distribution

  • 04015630997060 ()
3510620190

  • Phenobarbital therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
20737976122
In Commercial Distribution

  • 04015630993468 ()
20737976122

  • Barbiturate IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
3376222190
Not in Commercial Distribution

  • 04015630996933 ()
3376222190

  • Lidocaine therapeutic drug monitoring IVD, reagent
SCALER, DOUBLE END,OFFSET SICKLE MONTANA JACK-20, DURALITE COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
CESCNMJ-20
In Commercial Distribution

  • 00840018619302 ()


  • Manual dental scaler, reusable
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