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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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3M™ Ioban™ CHG Chlorohexidine Gluconate Incise Drape (2% w/w CHG), 8850EZSB, 22 in x 17 in (56cm x 45cm), 100/CS
3M COMPANY
8850EZSB
In Commercial Distribution

  • 50707387814064 ()
  • 10707387814066 ()
8850EZSB

  • Patient surgical drape, single-use
3M™ Ioban™ CHG Chlorohexidine Gluconate Incise Drape (2% w/w CHG), 8840EZSB, 13 in x 13 in (34cm x 35cm), 100/CS
3M COMPANY
8840EZSB
In Commercial Distribution

  • 50707387814057 ()
  • 10707387814059 ()
8840EZSB

  • Patient surgical drape, single-use
An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
NANO-DITECH CORPORATION
TF8147
In Commercial Distribution

  • 00895160002526 ()
  • 10895160002523 ()
TF8147

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myocardial infarction patients
NANO-DITECH CORPORATION
TF3151
In Commercial Distribution

  • 00895160002410 ()
  • 10895160002417 ()
TF3151

  • Troponin I IVD, kit, fluorescent immunoassay
The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.
BIOMERICA, INC.
7024
In Commercial Distribution

  • 00083059070248 ()


  • Calcitonin IVD, kit, enzyme immunoassay (EIA)
Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.
Affinity Biologicals Inc
LFGCP0181
In Commercial Distribution

  • 10629009031814 ()
  • 10629009030015 ()
  • 16290090031812 ()


  • Multiple coagulation factor IVD, control
Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.
Affinity Biologicals Inc
LFGCP0125
In Commercial Distribution

  • 10629009031258 ()
  • 10629009030015 ()
  • 16290090031256 ()


  • Multiple coagulation factor IVD, control
Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.
Affinity Biologicals Inc
LFGCP0105
In Commercial Distribution

  • 10629009031050 ()
  • 10629009030015 ()
  • 16290090031058 ()


  • Multiple coagulation factor IVD, control
Curaplex Select IV Admin Set, 15 Drop, 89 in, 1 LL Site, 1 PP Site, 6 in Ext Set w/Pinch Clamp 50/cs
BOUND TREE MEDICAL, LLC
15-10411
In Commercial Distribution

  • 00815277023269 ()
  • 00815277023252 ()
15-10411

  • Basic intravenous administration set, noninvasive
Curaplex Select IV Admin Set, 10 Drop, 83 in, 1 LL Site, 1 PP Site, 6 in Ext Set w/Pinch Clamp 50/cs
BOUND TREE MEDICAL, LLC
10-83611
In Commercial Distribution

  • 00815277023047 ()
  • 00815277023030 ()
10-83611

  • Basic intravenous administration set, noninvasive
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