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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Alinity i CA 125 II Calibrators
Abbott GmbH
08P4901
In Commercial Distribution

  • 00380740131036 ()
08P4901

  • Cancer antigen 125 (CA125) IVD, calibrator
DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter
CUSTOM PACK BB11S99R12 CHICO CA 1
MEDTRONIC, INC.
BB11S99R12
In Commercial Distribution

  • 00763000848446 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R11 CHICO CA 1
MEDTRONIC, INC.
BB11S99R11
In Commercial Distribution

  • 00763000845018 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY10J00R12 ECC SMALL CA
MEDTRONIC, INC.
HY10J00R12
In Commercial Distribution

  • 00763000467449 ()


  • Cardiopulmonary bypass system blood tubing set
HUMIDIFIER,DRY,HIGH FLOW,10/CA
BOUND TREE MEDICAL, LLC
301-P3050
In Commercial Distribution

  • 00810071638008 ()
  • 00810071637285 ()
301-P3050EA

  • Non-heated respiratory humidifier
RHK,CA,TORONTO EAST AVANTA DT
MEDLINE INDUSTRIES, INC.
VASC1623
In Commercial Distribution

  • 40198459155834 ()
  • 10198459155833 ()
VASC1623

  • General surgical procedure kit, non-medicated, single-use
VITROS Immunodiagnostic Products CA 19-9 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800035
In Commercial Distribution

  • 10758750000555 ()
  • 20758750000552 ()
6800035

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 15-3 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800033
In Commercial Distribution

  • 10758750000531 ()
  • 20758750000538 ()
6800033

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA (Calcium) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC251
In Commercial Distribution

  • 00817302020434 ()

  • Total Volume: 101 Milliliter
  • Kit contains 1 R1 bottle and 1 package insert
CC251

  • Calcium (Ca2+) IVD, kit, spectrophotometry
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