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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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A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
BIO-MED DIAGNOSTICS, INC.
1223
In Commercial Distribution

  • B08812234 ()
  • B08812230 ()
  • B08812232 ()
21-223-001

  • Chromogenic Salmonella species agar culture medium IVD
For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or genitourinary swabs.
BIO-MED DIAGNOSTICS, INC.
1113
In Commercial Distribution

  • B08811134 ()
  • B08811130 ()
  • B08811132 ()
21-113-001

  • Multiple Candida/yeast species culture isolate identification IVD, kit
For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
BIO-MED DIAGNOSTICS, INC.
1103
In Commercial Distribution

  • B08811034 ()
  • B08811030 ()
  • B08811032 ()
21-103-001

  • Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
SPN-1005
In Commercial Distribution

  • B090SPN10051 ()
  • B090SPN10050 ()
  • B090SPN10052 ()
SPN-1005

  • Torque manipulation device
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.50-065
In Commercial Distribution

  • B090S6500651 ()
  • B090S6500650 ()
  • B090S6500652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.50mm
S6.50-065

  • Peripheral angioplasty balloon catheter, basic
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.25-065
In Commercial Distribution

  • B090S6250650 ()
  • B090S6250651 ()
  • B090S6250652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.25mm
S6.25-065

  • Peripheral angioplasty balloon catheter, basic
The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100-3
In Commercial Distribution

  • B090MT1010031 ()
  • B090MT1010030 ()
  • B090MT1010032 ()
MT10-100-3

  • Thrombectomy tubing set, non-electronic
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-135-H
In Commercial Distribution

  • B090C14135H1 ()
  • B090C14135H0 ()
  • B090C14135H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-135-H

  • Vascular guide-catheter, single-use
The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1033
In Commercial Distribution

  • B090ASP10331 ()
  • B090ASP10330 ()
  • B090ASP10332 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 7 French
ASP-1033

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1021
In Commercial Distribution

  • B090ASP10211 ()
  • B090ASP10210 ()
  • B090ASP10212 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
ASP-1021

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
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