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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BB Retractor Left (Stainless Steel)
Modern Surgical Instruments LLC
769-13
In Commercial Distribution

  • 00810130200320 ()


  • Self-retaining surgical retractor, reusable
BB Retractor Right (Stainless Steel)
Modern Surgical Instruments LLC
769-08
In Commercial Distribution

  • 00810130200313 ()


  • Self-retaining surgical retractor, reusable
CUSTOM PACK BB11X80R3 BB PUMP
MEDTRONIC, INC.
BB11X80R3
In Commercial Distribution

  • 00763000763985 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11X80R2 BB PUMP
MEDTRONIC, INC.
BB11X80R2
In Commercial Distribution

  • 00763000715656 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11P03R CITRS BB
MEDTRONIC, INC.
BB11P03R
In Commercial Distribution

  • 00763000496944 ()


  • Cardiopulmonary bypass system blood tubing set
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-3
In Commercial Distribution

  • 00856743007048 ()
150-3

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-2
In Commercial Distribution

  • 00856743007031 ()
150-2

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-1
In Commercial Distribution

  • 00856743007024 ()
150-1

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150
In Commercial Distribution

  • 00856743007017 ()
150

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ro
In Commercial Distribution

  • 00850011135228 ()

  • 2 tests
401ro

  • Multiple cardiac marker IVD, control
Cardiac Positive Control, 0.5 mL
MARDX DIAGNOSTICS, INC.
10-5402
In Commercial Distribution

  • 05391516747806 ()
10-5402

  • Multiple cardiac marker IVD, control
Monkey Heart 4 Well Slides, 12 each/pack
MARDX DIAGNOSTICS, INC.
10-5404
In Commercial Distribution

  • 05391516747790 ()
10-5404

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Anti Cardiac Antibody IFA Test System, 48 Tests
MARDX DIAGNOSTICS, INC.
10-5448
In Commercial Distribution

  • 05391516747783 ()
10-5448

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Monkey Heart 8 Well Slides, Pack of 12
MARDX DIAGNOSTICS, INC.
10-5408
In Commercial Distribution

  • 05391516747813 ()
10-5408

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401db
In Commercial Distribution

  • 00859110005616 ()

  • 2 tests
401db

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401bc
In Commercial Distribution

  • 00859110005609 ()

  • 2 tests
401bc

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ab
In Commercial Distribution

  • 00859110005593 ()

  • 2 tests
401ab

  • Multiple cardiac marker IVD, control
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1065x
In Commercial Distribution

  • 00867556000171 ()


  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016487
In Commercial Distribution

  • 03610522248902 ()
12016487

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016486
In Commercial Distribution

  • 03610522248896 ()
12016486

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016485
In Commercial Distribution

  • 03610522248889 ()
12016485

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016484
In Commercial Distribution

  • 03610522248872 ()
12016484

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016475
In Commercial Distribution

  • 03610522248698 ()
12016475

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016474
In Commercial Distribution

  • 03610522248681 ()
12016474

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016473
In Commercial Distribution

  • 03610522248674 ()
12016473

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016472
In Commercial Distribution

  • 03610522248667 ()
12016472

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016450
In Commercial Distribution

  • 03610522248407 ()
12016450

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016449
In Commercial Distribution

  • 03610522248391 ()
12016449

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016448
In Commercial Distribution

  • 03610522248384 ()

  • 6 x 3 ml
12016448

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016447
In Commercial Distribution

  • 03610522248377 ()
12016447

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009966
In Commercial Distribution

  • 03610522114436 ()
12009966

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009965
In Commercial Distribution

  • 03610522114429 ()
12009965

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1A MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009964
In Commercial Distribution

  • 03610522114412 ()
12009964

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009963
In Commercial Distribution

  • 03610522114405 ()
12009963

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009962
In Commercial Distribution

  • 03610522114399 ()
12009962

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009961
In Commercial Distribution

  • 03610522114382 ()
12009961

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009960
In Commercial Distribution

  • 03610522114375 ()
12009960

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009959
In Commercial Distribution

  • 03610522114368 ()
12009959

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1A (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009958
In Commercial Distribution

  • 03610522114351 ()
12009958

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 3 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009957
In Commercial Distribution

  • 03610522114344 ()
12009957

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009956
In Commercial Distribution

  • 03610522114337 ()
12009956

  • Multiple cardiac marker IVD, control
InteliQ Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12009955
In Commercial Distribution

  • 03610522114320 ()
12009955

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 3 MiniPak (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12006371
In Commercial Distribution

  • 03610521174943 ()
12006371

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 2 MiniPak (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12006370
In Commercial Distribution

  • 03610521174936 ()
12006370

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12006369
In Commercial Distribution

  • 03610521174929 ()
12006369

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Troponins Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12006239
In Commercial Distribution

  • 03610521174905 ()
12006239

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004817
In Commercial Distribution

  • 03610520865323 ()
12004817

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004816
In Commercial Distribution

  • 03610520865316 ()
12004816

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004815
In Commercial Distribution

  • 03610520865309 ()
12004815

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12004814
In Commercial Distribution

  • 03610520865293 ()
12004814

  • Multiple cardiac marker IVD, control
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