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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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BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 Rotaflow, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Temperature Probe.
DATASCOPE CORP.
BEQ-TOP 54501
Not in Commercial Distribution

  • 00607567213364 ()
709000498R01

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 800ml, BMU Cell Ven. 1/4, Blood Microfilter System SQ 40 S, Prebypass filter w/o vent Porous Media 3/8x3/8, Temperature Probe,
DATASCOPE CORP.
BEQ-T 37313
In Commercial Distribution

  • 00607567213302 ()
709000606

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000ml - 2 spike ports, BEQ-RF32 Rotaflow, CDI Sat Cell 3/8" Systems 100, Blood Microfilter Systems SQ 40 S, prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 5900
In Commercial Distribution

  • 00607567212275 ()
701050228R01

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S,Gas Filter
DATASCOPE CORP.
BEQ-TOP 38300
In Commercial Distribution

  • 00607567212060 ()
701055862R01

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Gas Filter
DATASCOPE CORP.
BEQ-T 44802
Not in Commercial Distribution

  • 00607567211353 ()
709000394

  • Cardiopulmonary bypass system blood tubing set
BO-HMOD 70000-USA Adult Quadrox iD, BO-VHK 31000 Venous Res. Pediatric (MACE), BO-RF32 RotaFlow, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BO-TOP 26403
Not in Commercial Distribution

  • 00607567210585 ()
709000308

  • Cardiopulmonary bypass system blood tubing set
BO-VHK 71000 Venous Reservoir, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-T 21902
Not in Commercial Distribution

  • 00607567203341 ()
701055521

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 8101
Not in Commercial Distribution

  • 00607567201095 ()
701049524

  • Cardiopulmonary bypass system blood tubing set
PLATE DRY CLI GRAM+ ID AUTO -A semi-quantitative test intended for the automated identification of Gram negative bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GNID
In Commercial Distribution

  • 00848838074325 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
No Description
GREAT BASIN SCIENTIFIC, INC.
GBSIDR-10
In Commercial Distribution

  • B178GBSIDR102 ()
  • B178GBSIDR100 ()
GBSIDR-10

  • MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
  • MRSE nucleic acid detection IVD, kit, nucleic acid technique (NAT)
  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit
  • MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
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