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

  • 00883873952863 ()
21340-000606

  • Emergency/ambulatory healthcare software
LIFENET Connect Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873952856 ()
21340-000607

  • Emergency/ambulatory healthcare software
LIFENET CONSULT RELEASE5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873863770 ()
21340-000837

  • Emergency/ambulatory healthcare software
LIFENET CONSULT INTERNATIONAL RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873863732 ()
21340-000838

  • Emergency/ambulatory healthcare software
MULTITECH 3G GATEWAY - ATT
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863084 ()
21996-000104

  • Emergency/ambulatory healthcare software
MULTITECH 3G GATEWAY - ATT KORE
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863077 ()
21996-000105

  • Emergency/ambulatory healthcare software
MULTITECH 3G GATEWAY - VERIZON
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863060 ()
21996-000106

  • Emergency/ambulatory healthcare software
MULTITECH 3G GATEWAY - VERIZON KORE
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863053 ()
21996-000107

  • Emergency/ambulatory healthcare software
MULTITECH 3G GATEWAY - INTL
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863046 ()
21996-000108

  • Emergency/ambulatory healthcare software
LIFENET ASSET EXPORT 32-BIT 5.4.1.2
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873862902 ()
21340-000843

  • Emergency/ambulatory healthcare software
LIFENET ASSET EXPORT 64-BIT 5.4.1.2
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873862896 ()
21340-000844

  • Emergency/ambulatory healthcare software
LIFENET PC Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873908181 ()
21340-000769

  • Emergency/ambulatory healthcare software
LIFENET Export 32-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873907870 ()
21340-000778

  • Emergency/ambulatory healthcare software
LIFENET Export 64-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873907863 ()
21340-000779

  • Emergency/ambulatory healthcare software
LIFENET Adapter 32-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903438 ()
21340-000794

  • Emergency/ambulatory healthcare software
LIFENET Adapter 64-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903421 ()
21340-000795

  • Emergency/ambulatory healthcare software
LIFENET SERVER
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903278 ()
21340-000796

  • Emergency/ambulatory healthcare software
LIFENET ALERT 32-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901878 ()
21340-000800

  • Emergency/ambulatory healthcare software
LIFENET ALERT 64-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901861 ()
21340-000801

  • Emergency/ambulatory healthcare software
LIFENET Mobile Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873889749 ()
21340-000824

  • Emergency/ambulatory healthcare software
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