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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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ACCURUN® - 00816784020765

ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0016
In Commercial Distribution

  • 00816784020765 ()

  • Total Volume: 15 Milliliter
2000-0016

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020741

No Description
Lgc Clinical Diagnostics, Inc.
2000-0079
In Commercial Distribution

  • 00816784020741 ()


  • Multiple blood-borne virus antigen/antibody IVD, control

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369229

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
1 test/kit
In Commercial Distribution

  • 06974849369229 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369236

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369236 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Lumipulse Infectious Disease Controls - 04987270235584

No Description
FUJIREBIO INC.
235584
In Commercial Distribution

  • 04987270235584 ()

  • Number of bottles per kit = 8
  • Total mLs per bottle = 3/3/2.5


  • Multiple blood-borne virus antigen/antibody IVD, control

SpO2.COM® NRC-P12 Patient Cable - 00843997001380

No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-180 Patient Cable - 00843997001359

No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable

NA - 04260498580002

No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling

Medline Industries, Inc. - 10195327697006

HEART B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ53589G
In Commercial Distribution

  • 10195327697006 ()
DYNJ53589G

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327695446

LAVH PART B
MEDLINE INDUSTRIES, INC.
DYNJV0312D
In Commercial Distribution

  • 40195327695447 ()
  • 10195327695446 ()
DYNJV0312D

  • General surgical procedure kit, non-medicated, single-use
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