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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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MHHS TMC ¼ with BB & QiD Pedi - 00607567212039

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, CDI Sat Cell 1/4" System 100, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 25503
In Commercial Distribution

  • 00607567212039 ()
709000473

  • Cardiopulmonary bypass system blood tubing set

Custom Tubing Pack with Quadrox iD - 00607567210585

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

ECC Pack 1/4" with Roller - 00607567206335

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 27609
Not in Commercial Distribution

  • 00607567206335 ()
701065504

  • Cardiopulmonary bypass system blood tubing set

Open heart pack with NO VKMO - 00607567205925

BEQ-FR32 Rotaflow Prebypass filter Gas filter
DATASCOPE CORP.
BEQ-T 4903
In Commercial Distribution

  • 00607567205925 ()
701066664

  • Cardiopulmonary bypass system blood tubing set

ECC Pack 3/8 with Rotaflow - 00607567205642

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 3/8, BEQ-RF32 RotaFlow, BC 60 plus, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Temperature Probe
DATASCOPE CORP.
BEQ-TOP 27610
Not in Commercial Distribution

  • 00607567205642 ()
701065622

  • Cardiopulmonary bypass system blood tubing set

ECC Pack 1/4 with Rotaflow - 00607567205628

BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, BEQ-RF32 RotaFlow, BC 60 plus, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter, Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 27611
Not in Commercial Distribution

  • 00607567205628 ()
701066061

  • Cardiopulmonary bypass system blood tubing set

MCV Infant ECC Pack with QPiD - 00607567205482

701050970 BEQ-HMOD 30000-USA Pediatric Quadrox iD 701066544 BO-VHK 310000 Venous res Pediatric 701054444 Better Bladder 701020489 BEQ-RF32 RotaFLow 701045763 Gas Filter
DATASCOPE CORP.
BEQ-TOP 28901
Not in Commercial Distribution

  • 00607567205482 ()
701056771

  • Cardiopulmonary bypass system, non-roller type

BIA310 Implant 4mm with 8mm abutment - 09321502043939

N/A
Cochlear Bone Anchored Solutions AB
P1340889
In Commercial Distribution

  • 09321502043939 ()

  • Implant 4 mm with 8 mm Abutment
  • Length: 8 Millimeter
P1340889

  • Craniofacial bone screw, non-bioabsorbable

BIA310 Implant 4mm with 10mm abutment - 09321502043922

N/A
Cochlear Bone Anchored Solutions AB
P1340890
In Commercial Distribution

  • 09321502043922 ()

  • Length: 10 Millimeter
  • Implant 4 mm with 10 mm Abutment
P1340890

  • Craniofacial bone screw, non-bioabsorbable

BIA310 Implant 4mm with 12mm abutment - 09321502043915

N/A
Cochlear Bone Anchored Solutions AB
P1340891
In Commercial Distribution

  • 09321502043915 ()

  • Implant 4 mm with 12 mm Abutment
  • Length: 12 Millimeter
P1340891

  • Craniofacial bone screw, non-bioabsorbable
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