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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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Ultrasound Gel, 20g Packet, Sterile
SVS LLC
3401
In Commercial Distribution

  • 20818566012856 ()
  • 10818566012859 ()
  • 00818566012852 ()


  • Topical coupling gel, sterile
GEL,ULTRASOUND,BOTTLE,8.5-OZ,CLEAR
MEDLINE INDUSTRIES, INC.
CTR001305
In Commercial Distribution

  • 10035135013059 ()
  • 00035135013052 ()
CTR001305

  • Skin topical coupling gel
PRO-LAB Mucolyse is a sputum liquefying agent used to digest and thin out the sputum, thus enhancing the isolation of organisms responsible for chronic lung disease
PRO-LAB, INCORPORATED
PL.701
In Commercial Distribution

  • 10628429001001 ()
PL.701

  • Sputum liquefaction/decontamination reagent IVD
BCYE Agar Slant, 20x125mm tube, order by the package of 20 Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria.
HARDY DIAGNOSTICS
L24
In Commercial Distribution

  • 00816576027941 ()
  • 00819398028127 ()
L24

  • Enriched agar culture medium IVD
Middlebrook 7H11 Slant, 20x125 tube, 20 tubes/box For the cultivation of Mycobacterium spp.
HARDY DIAGNOSTICS
C36
In Commercial Distribution

  • 00819398020282 ()
  • 00819398027991 ()
C36

  • Enriched agar culture medium IVD
Bovine Serum Albumin 0.2%, 3ml each, for enhanced growth of mycobacteria; optically clear, shatter resistant, polycarbonate tube, 20 per kit Used for the preparation of specimens for AFB culture. A growth stimulant for Mycobacterium tuberculosis.
HARDY DIAGNOSTICS
Z81
In Commercial Distribution

  • 00819398026383 ()
  • 00819398026390 ()
Z81

  • Culture medium nutrient supplement IVD
Fluid Thioglycollate with Hemin and Vitamin K, 16x125mm tube, order by the package of 20 For the cultivation of aerobic, microaerophilic, and anaerobic microorganisms in normally sterile materials.
HARDY DIAGNOSTICS
K73
In Commercial Distribution

  • 00819398023979 ()
  • 00819398026239 ()
K73

  • Enriched broth culture medium IVD
Middlebrook ADC Supplement, 20ml, 1 ounce bottle, order by the package of 10 For use as a supplement for Middlebrook media.
HARDY DIAGNOSTICS
X95
In Commercial Distribution

  • 00819398024556 ()
  • 00819398024563 ()
X95

  • Culture medium nutrient supplement IVD
Middlebrook 7H11 Selective, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H11 Agar is recommended for use in the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
X28
In Commercial Distribution

  • 00819398024259 ()
  • 00819398024266 ()
X28

  • Enriched agar culture medium IVD
Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
X26
In Commercial Distribution

  • 00819398024235 ()
  • 00819398024242 ()
X26

  • Enriched agar culture medium IVD
Middlebrook 7H11 Agar, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H11 Agar is recommended for use in the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
X25
In Commercial Distribution

  • 00819398024211 ()
  • 00819398024228 ()
X25

  • Enriched agar culture medium IVD
Middlebrook 7H11 Slant, 3ml, 13x100mm tube slant, order by the package of 20 For the isolation and cultivation of Mycobacterium spp.
HARDY DIAGNOSTICS
R49
Not in Commercial Distribution

  • 00819398023528 ()
  • 00819398023535 ()
R49

  • Enriched agar culture medium IVD
Chocolate Agar Slant, 5.5ml, 16x100mm tube, order by the package of 20 (GC Agar Base with 1% hemoglobin and enrichments) For the cultivation of fastidious bacteria.
HARDY DIAGNOSTICS
L37
In Commercial Distribution

  • 00819398022286 ()
  • 00819398022293 ()
L37

  • Enriched agar culture medium IVD
Loeffler's Slant, 5.5ml, 16x100mm tube, order by the package of 20 For the cultivation of Corynebacterium diphtheriae from clinical specimens.
HARDY DIAGNOSTICS
L28
In Commercial Distribution

  • 00819398022187 ()
  • 00819398022194 ()
L28

  • Enriched agar culture medium IVD
Brain Heart Infusion Broth with Hemin and Vitamin K (BHI Broth w/H&K), 16x125mm tube, 10ml fill, order by the package of 20 For the cultivation of fastidious bacteria.
HARDY DIAGNOSTICS
K75
In Commercial Distribution

  • 00819398021708 ()
  • 00819398021715 ()
K75

  • Enriched broth culture medium IVD
Columbia Broth, 8ml fill, 16x125mm glass tube, order by the package of 20 For use in the cultivation of fastidious microorganisms
HARDY DIAGNOSTICS
K74
Not in Commercial Distribution

  • 00819398021685 ()
  • 00819398021692 ()
K74

  • Enriched broth culture medium IVD
Chopped Meat Glucose Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Chopped Meat Media is recommended for the cultivation of microaerophilic, facultative and obligate anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
AG19H
In Commercial Distribution

  • 00819398021463 ()
  • 00819398021470 ()
AG19H

  • Enriched broth culture medium IVD
Thioglycollate with H & K, 8mL, 16x100mm tube, 20 tubes.box (Thioglycollate without indicator with hemin and vitamin K) For the cultivation of bacteria, including fastidious anaerobes. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
K234
In Commercial Distribution

  • 00819398021128 ()
  • 00819398021135 ()
K234

  • Enriched broth culture medium IVD
Thioglycollate with H & K, 16x100mm Tube, 5ml. Hardy Diagnostics Thioglycollate Media is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms.
HARDY DIAGNOSTICS
K22
In Commercial Distribution

  • 00819398021067 ()
  • 00819398021074 ()
K22

  • Enriched broth culture medium IVD
Cooked Meat Medium, 20x125mm Tube, 15ml. Hardy Diagnostics Cooked Meat Medium is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
K219
In Commercial Distribution

  • 00819398021043 ()
  • 00819398021050 ()
K219

  • Enriched broth culture medium IVD
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