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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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Defibrillator ,MAIN, R SERIES, BLS, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, CF/STD, DMST, REFURB
Zoll Medical Corporation
10000001001130013
In Commercial Distribution

  • 00847946002008 ()

  • 8.2" x 10.5" x 12.5"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN, R SERIES, PLUS, MAN-1, 3/5 LD, STD ECG, AC PWR, SPO2, PACE, CF/USB, DMST
Zoll Medical Corporation
10000001001110013
In Commercial Distribution

  • 00847946001995 ()

  • 8.2" x 10.5" x 12.5"


  • Rechargeable professional automated external defibrillator
Defibrillator ,R SERIES, MAIN, ALS, 3/5 LD, AC PWR, STD ECG, PACE, ETCO2, CF/USB, DMST, REFURB
Zoll Medical Corporation
10000000301110012
In Commercial Distribution

  • 00847946001971 ()

  • 8.2" x 10.5" x 12.5"


  • Rechargeable professional automated external defibrillator
U.S Only IFU, Manual & CDs, Anti-CCP IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865001366 ()

  • 1 Each
6653265E

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex
Celiac IgA Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution

  • 00847865001250 ()

  • 1 Each
6652370B

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgG
BIO-RAD LABORATORIES, INC.
425-2340
In Commercial Distribution

  • 00847817018541 ()

  • 96 Tests
4252340

  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)
Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgA
BIO-RAD LABORATORIES, INC.
425-2320
In Commercial Distribution

  • 00847817018534 ()

  • 96 Tests
4252320

  • Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA
BIO-RAD LABORATORIES, INC.
425-2260
In Commercial Distribution

  • 00847817018336 ()

  • 96 Tests
4252260

  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgA Test Kit
BIO-RAD LABORATORIES, INC.
425-2040
In Commercial Distribution

  • 00847817018220 ()

  • 96 Tests
425-2040

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgM Test Kit
BIO-RAD LABORATORIES, INC.
425-2020
In Commercial Distribution

  • 00847817018213 ()

  • 96 Tests
425-2020

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
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