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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CNDT 200SH20 CONTEGRA SUPP HDE
MEDTRONIC, INC.
200SH20
In Commercial Distribution

  • 00643169616875 ()

  • Valve Size 20 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200SH18 CONTEGRA SUPP HDE
MEDTRONIC, INC.
200SH18
In Commercial Distribution

  • 00643169616868 ()

  • Valve Size 18 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200SH16 CONTEGRA SUPP HDE
MEDTRONIC, INC.
200SH16
In Commercial Distribution

  • 00643169616851 ()

  • Valve Size 16 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200SH14 CONTEGRA SUPP HDE
MEDTRONIC, INC.
200SH14
In Commercial Distribution

  • 00643169616844 ()

  • Valve Size 14 MM


  • Pulmonary open-surgery heart valve bioprosthesis
CNDT 200SH12 CONTEGRA SUPP HDE
MEDTRONIC, INC.
200SH12
In Commercial Distribution

  • 00643169616837 ()

  • Valve Size 12 MM


  • Pulmonary open-surgery heart valve bioprosthesis
INS 37800 ENTERRA II NON-PARYLENE US
MEDTRONIC, INC.
37800
Not in Commercial Distribution

  • 00643169614246 ()


  • Gastric electrical stimulation system
DELIV SYS NU1022 ENSEMBLE US
MEDTRONIC, INC.
NU1022
Not in Commercial Distribution

  • 00643169588455 ()

  • Outer Balloon Size 22 MM


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS NU1018 ENSEMBLE US
MEDTRONIC, INC.
NU1018
Not in Commercial Distribution

  • 00643169588431 ()

  • Outer Balloon Size 18 MM


  • Pulmonary transcatheter heart valve bioprosthesis
CliniMACS® Tubing Set (LS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.
Miltenyi Biotec B.V. & Co. KG
73205
In Commercial Distribution

  • 04049934004841 ()
162-01

  • Magnetic cell separation system tubing set
CliniMACS® Tubing Set (TS) is a single-use, sterile, disposable tubing set with two proprietary cell separation columns used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 Reagent System is an in vitro medical device system used to select and enrich CD34+ cells from HPC, Apheresis while passively depleting other cells, such as CD3+ T cells, which cause graft versus host disease. The system is based on "magnetically-activated cell sorting" (MACS) employing antibodies conjugated to iron-containing particles that can be attracted to a magnetic field (referred to as “magnetic labeling”). Using the specificity of anti-CD34 antibody interaction with cell surface CD34 antigen found on hematopoietic progenitor cells, the system enriches CD34+ cells from HPC, Apheresis by passing the antibody-labeled cell suspension through a separation column with a strong magnetic gradient. The separation column retains the magnetically labeled CD34+ target cells while unlabeled cells flow through and are collected in the Negative Fraction Bag. Several automated washing steps are performed, disposing most of the liquid into the Buffer Waste Bag. The magnetically-selected CD34+ cells are released from the separation column when the magnet is disengaged, removing the magnetic field, and the target CD34+ cells are eluted into the Cell Collection Bag.
Miltenyi Biotec B.V. & Co. KG
73105
In Commercial Distribution

  • 04049934004834 ()
161-01

  • Magnetic cell separation system tubing set
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