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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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OCS Heart System - B00936463

OCS Cardioplegic Arrest Set
TRANSMEDICS, INC.
1421
In Commercial Distribution

  • B00936463 ()
  • B00936655 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1421

  • Donor-organ preservation/transport perfusion initiation/termination set

OCS Heart System - B00948913

OCS Heart Solution Line Set
TRANSMEDICS, INC.
1457
In Commercial Distribution

  • B00948913 ()
  • B00948925 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1457

  • Donor-organ preservation/transport perfusion initiation/termination set

OCS Lung System - B00943281

OCS Lung Perfusion Initiation Set
TRANSMEDICS, INC.
2402
In Commercial Distribution

  • B00943281 ()
  • B00937703 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2402

  • Donor-organ preservation/transport perfusion initiation/termination set

LIAISON QUANTIferon TB Gold Plus - 08056771602945

USA manufactured kit
Diasorin Inc.
311020
Not in Commercial Distribution

  • 08056771602945 ()


  • Pregnenolone IVD, kit, enzyme immunoassay (EIA)

BD Onclarity™ HPV LBC Diluent Tubes - 30382904453283

Tube HPV LBC Diluent US ThinPrep 400 ea
BECTON, DICKINSON AND COMPANY
445328
In Commercial Distribution

  • 00382904453282 ()
  • 30382904453283 ()
445328

  • Human papillomavirus (HPV) nucleic acid IVD, reagent

BD Onclarity™ HPV Assay Diluent for BD COR™ - 30382904440832

HPV Diluent for BD COR US
BECTON, DICKINSON AND COMPANY
444083
In Commercial Distribution

  • 00382904440831 ()
  • 30382904440832 ()
444083

  • Human papillomavirus (HPV) nucleic acid IVD, reagent

BD Onclarity HPV Self Collection Diluent Tube - 30382904454167

BD Onclarity HPV Self Collection Diluent Tube
BECTON, DICKINSON AND COMPANY
445416
In Commercial Distribution

  • 00382904454166 ()
  • 30382904454167 ()
445416

  • Human papillomavirus (HPV) nucleic acid IVD, reagent

BD Onclarity™ HPV SurePath™ Diluent Tubes - 30382904453290

Tube HPV LBC Diluent US Surepath 400 ea
BECTON, DICKINSON AND COMPANY
445329
In Commercial Distribution

  • 00382904453299 ()
  • 30382904453290 ()
445329

  • Human papillomavirus (HPV) nucleic acid IVD, reagent

digene® Wash Buffer Concentrate - 14053228002014

digene® Wash Buffer Concentrate (paired with 5199-00016 High-risk 4-plate)
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002014 ()
5100-00047

  • Human papillomavirus (HPV) antigen IVD, reagent

CONTOUR® NEXT - 00301937283352

Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use
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