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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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ONLINE TDM Quinidine - 07613336147917

No Description
Roche Diagnostics GmbH
08252670190
In Commercial Distribution

  • 07613336147917 ()
08252670190

  • Quinidine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Procainamide - 07613336147900

No Description
Roche Diagnostics GmbH
08252661190
In Commercial Distribution

  • 07613336147900 ()
08252661190

  • Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ONLINE TDM N-acetylprocainamide - 07613336147870

No Description
Roche Diagnostics GmbH
08252637190
In Commercial Distribution

  • 07613336147870 ()
08252637190

  • N-acetylprocainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ONLINE TDM Theophylline - 04015630997169

No Description
Roche Diagnostics GmbH
3531066190
Not in Commercial Distribution

  • 04015630997169 ()
3531066190

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Phenytoin - 04015630997138

No Description
Roche Diagnostics GmbH
3516989190
Not in Commercial Distribution

  • 04015630997138 ()
3516989190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Phenobarbital - 04015630997060

No Description
Roche Diagnostics GmbH
3510620190
Not in Commercial Distribution

  • 04015630997060 ()
3510620190

  • Phenobarbital therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Abuscreen OnLine Barbiturates - 04015630993468

No Description
Roche Diagnostics GmbH
20737976122
In Commercial Distribution

  • 04015630993468 ()
20737976122

  • Barbiturate IVD, kit, chemiluminescent immunoassay

ONLINE TDM Lidocaine - 04015630996933

No Description
Roche Diagnostics GmbH
3376222190
Not in Commercial Distribution

  • 04015630996933 ()
3376222190

  • Lidocaine therapeutic drug monitoring IVD, reagent

LIFENET Connect - 00883873952863

LIFENET Connect RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873952863 ()
21340-000606

  • Emergency/ambulatory healthcare software

LIFENET Connect Gateway - 00883873952856

LIFENET Connect Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873952856 ()
21340-000607

  • Emergency/ambulatory healthcare software
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