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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 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

Molded Products, Inc. - B144UM872360

STERILE ACCESS & RETURN LINE SET
MOLDED PRODUCTS, INC.
UM-872-36
In Commercial Distribution

  • B144UM872360 ()
  • B144UM872361 ()
  • B144UM872364 ()
UM-872-36

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC8750

Sterile DIN to Male DIN Connector
MOLDED PRODUCTS, INC.
MPC-875
In Commercial Distribution

  • B144MPC8753 ()
  • B144MPC8751 ()
  • B144MPC8750 ()
MPC-875

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC8700

Sterile Bloodline Extension
MOLDED PRODUCTS, INC.
MPC-870
In Commercial Distribution

  • B144MPC8703 ()
  • B144MPC8701 ()
  • B144MPC8700 ()
MPC-870

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC8650

Sterile Female Luer to Male DIN Connector
MOLDED PRODUCTS, INC.
MPC-865
In Commercial Distribution

  • B144MPC8651 ()
  • B144MPC8650 ()
  • B144MPC8653 ()
MPC-865

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC855S250PP3

Sterile DIN Adapter, Polypropylene, Fits 1/4" ID Tubing
MOLDED PRODUCTS, INC.
MPC-855S.250PP
In Commercial Distribution

  • B144MPC855S250PP5 ()
  • B144MPC855S250PP4 ()
  • B144MPC855S250PP3 ()
  • B144MPC855NS250PP0 ()
MPC-855S.250PP

  • Haemodialysis blood tubing set, single-use
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