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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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M3:10A™ - G507M310A05000

Supplemented Growth Media with 10% FBS and Antibiotics
Incell Corporation, LLC
M310A0500
In Commercial Distribution

  • G507M310A05000 ()

  • Total Volume: 500 Milliliter
M310A0500

  • Cell culture medium IVD

M3:10A™ - G507M310A01000

Supplemented Growth Media with 10% FBS and Antibiotics
Incell Corporation, LLC
M310A0100
In Commercial Distribution

  • G507M310A01000 ()

  • Total Volume: 100 Milliliter
M310A0100

  • Cell culture medium IVD

AirLife - 10885403287138

FILTER HEPA W PLEATED MEDIA GSP 50/PK
Carefusion Finland 320 Oy
M1043237
Not in Commercial Distribution

  • 20885403287135 ()
  • 10885403287138 ()
M1043237

  • Microbial medical gas filter, single-use

NA - 00721902985287

FILTER 3L47R 4PK 1/2x3/8 POROUS MEDIA
MEDTRONIC, INC.
3L47R
Not in Commercial Distribution

  • 20721902985281 ()
  • 00721902985287 ()


  • Cardiopulmonary bypass system blood tubing set

N/A - 00819398028431

PEA w/SB/Tergitol 7 Agar 15x100 biplate, 10 plates per pack Differentiation and isolation of gram-negative and gram-positive organisms (as well as fermenting characteristics), preventing of Proteus swarming, differentiation of gram-positive organisms, early detector of yeast (growth on both PEA & T7 with white colonies).
HARDY DIAGNOSTICS
J120
In Commercial Distribution

  • 00819398028028 ()
  • 00819398028431 ()
J120

  • Multiple formulation agar culture medium IVD

N/A - 00816576028108

Blood Agar 5% / CLED Agar with Bile, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp.
HARDY DIAGNOSTICS
J65
In Commercial Distribution

  • 00816576028092 ()
  • 00816576028108 ()
J65

  • Multiple formulation agar culture medium IVD

N/A - 00816576027224

Blood Agar 5% / Group A Beta Strep Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
J92
Not in Commercial Distribution

  • 00816576027217 ()
  • 00816576027224 ()
J92

  • Multiple formulation agar culture medium IVD

N/A - 00816576027187

Brucella Agar with Hemin and Vitamin K /LKV (Laked Blood Kanamycin Vancomycin) Agar Biplate, 15x100 biplate, 10/pk For the cultivation of anaerobic bacteria and the selective isolation of Bacteroides spp.
HARDY DIAGNOSTICS
J67
In Commercial Distribution

  • 00816576027170 ()
  • 00816576027187 ()
J87

  • Multiple formulation agar culture medium IVD

N/A - 00816576026753

Blood Agar / CLED Agar / MacConkey Agar, 15x100mm Triplate, 7ml/section. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp. Hardy Diagnostics MacConkey Agar is recommended for use as a selective and differential medium for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens), on the basis of lactose fermentation.
HARDY DIAGNOSTICS
J315
In Commercial Distribution

  • 00816576026746 ()
  • 00816576026753 ()
J315

  • Multiple formulation agar culture medium IVD

N/A - 00816576026739

Blood Agar 5% / Eosin Methylene Blue (EMB), Levine Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens.
HARDY DIAGNOSTICS
J22
In Commercial Distribution

  • 00816576026722 ()
  • 00816576026739 ()
J22

  • Multiple formulation agar culture medium IVD
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