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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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Vaporflex® Handle and Shaft
Joimax GmbH
JVH28030
In Commercial Distribution

  • 04250337116790 ()
JVH28030

  • Radio-frequency ablation system
Vaporflex® Shaft 275
Joimax GmbH
JVHS28030
In Commercial Distribution

  • 04250337116783 ()
JVHS28030

  • Radio-frequency ablation system
Legato® Probe monopolar, Ball Tip, straight
Joimax GmbH
JMPP27025*
In Commercial Distribution

  • 04250337115243 ()
  • 04250337115250 ()
JMPP27025*

  • Radio-frequency ablation system
TNI softFlow 50
TNI medical AG
40610021
In Commercial Distribution

  • 04059163000415 ()
40610021

  • Professional high-flow respiratory unit, humidifying, manual
Vaporflex® Handle
Joimax GmbH
JVUH10010
In Commercial Distribution

  • 04250337103899 ()


  • Radio-frequency ablation system
Vaporflex® Handle and Shaft 320
Joimax GmbH
JVH32030
In Commercial Distribution

  • 04250337103875 ()


  • Radio-frequency ablation system
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
HVT-DPC-BR
VAPOTHERM, INC.
HVT-DPC-BR
In Commercial Distribution

  • 10841737105753 ()
  • 00841737105756 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT-BAT-BR
VAPOTHERM, INC.
HVT-BAT-BR
In Commercial Distribution

  • 00841737105749 ()


  • Professional high-flow respiratory unit, humidifying, manual
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