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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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Aspire Max 5 Aspiration Catheter 135cm - B090A51350

ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-135
In Commercial Distribution

  • B090A51352 ()
  • B090A51351 ()
  • B090A51350 ()
A5-135

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

Aspire Max 5 Aspiration Catheter 55cm - B090A50550

ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-055
In Commercial Distribution

  • B090A50552 ()
  • B090A50551 ()
  • B090A50550 ()
A5-055

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

Control 11F Mechanical Thrombectomy System - B090A110900

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.
A11-090
In Commercial Distribution

  • B090A110901 ()
  • B090A110900 ()
  • B090A110902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
A11-090

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

Control 11F Mechanical Thrombectomy System, 60cm - B090A110600

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.
A11-060
In Commercial Distribution

  • B090A110601 ()
  • B090A110600 ()
  • B090A110602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
A11-060

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

SPINR - B0905XGW0

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.
5X-GW
In Commercial Distribution

  • B0905XGW1 ()
  • B0905XGW0 ()
  • B0905XGW2 ()
5X-GW

  • Torque manipulation device

Aspire Aspirator 30ml - B09030ASP0

ASPIRE Mechanical Aspirators for aspiration of fluids from the body anywhere a syringe is used.
ZIEN MEDICAL TECHNOLOGIES, INC.
30-ASP
In Commercial Distribution

  • B09030ASP0 ()
  • B09030ASP1 ()
  • B09030ASP2 ()
30-ASP

  • General-purpose syringe, single-use

InTray® Mueller Hinton Chocolate Agar - B08824830

Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.
BIO-MED DIAGNOSTICS, INC.
2483
In Commercial Distribution

  • B08824834 ()
  • B08824830 ()
  • B08824832 ()
22-483-001

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

InTray® DM - B08820630

An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
BIO-MED DIAGNOSTICS, INC.
2063
In Commercial Distribution

  • B08820630 ()
  • B08820634 ()
  • B08820632 ()
22-063-000

  • Multiple dermatophyte species culture isolate identification IVD, kit

Saline Solution (0.85%) - B08816120

Saline Solution (0.85%) is a saline solution for viral specimens.
BIO-MED DIAGNOSTICS, INC.
1612
In Commercial Distribution

  • B08816120 ()
  • B08816121 ()
  • B08816122 ()
11-612-001

  • Saline suspension medium/diluent IVD

VTM-C19 Transit Tube - B08816020

The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans. Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
BIO-MED DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • B08816026 ()
  • B08816020 ()
  • B08816021 ()
11-602-001

  • Viral transport medium IVD
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