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® Shaft 275
Joimax GmbH
JVHS28030
In Commercial Distribution

  • 04250337116783 ()
JVHS28030

  • Radio-frequency ablation system
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
Microwave Tissue Ablation Applicator
ANGIODYNAMICS UK LIMITED
900-602-US
Not in Commercial Distribution

  • H787900602US0 ()

  • Length: 19 Centimeter


  • Microwave hyperthermia system applicator, intracorporeal
Microwave Tissue Ablation Applicator
ANGIODYNAMICS UK LIMITED
900-601-US
Not in Commercial Distribution

  • H787900601US0 ()

  • Length: 29 Centimeter


  • Microwave hyperthermia system applicator, intracorporeal
Microwave Tissue Ablation Applicator
ANGIODYNAMICS UK LIMITED
900-600-US
Not in Commercial Distribution

  • H787900600US0 ()

  • Length: 14 Centimeter


  • Microwave hyperthermia system applicator, intracorporeal
Microwave Tissue Ablation Applicator
ANGIODYNAMICS, INC.
700106003-US
In Commercial Distribution

  • H787700106003US0 ()
  • 15051684017862 ()

  • Length: 29 Centimeter


  • Microwave hyperthermia system applicator, intracorporeal
Microwave Tissue Ablation Applicator
ANGIODYNAMICS, INC.
700106002-US
In Commercial Distribution

  • H787700106002US0 ()
  • 15051684017855 ()

  • Length: 19 Centimeter


  • Microwave hyperthermia system applicator, intracorporeal
Microwave Tissue Ablation Applicator
ANGIODYNAMICS, INC.
700106001-US
In Commercial Distribution

  • H787700106001US0 ()
  • 15051684017848 ()

  • Length: 14 Centimeter


  • Microwave hyperthermia system applicator, intracorporeal
Thermo Pad Adapter Cable
ANGIODYNAMICS, INC.
700-102648
In Commercial Distribution

  • H7877001026480 ()
  • 15051684021494 ()


  • 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
Protective Cap f. Oxygen Inlet White, softFlow, 5 Pieces
TNI medical AG
40620061
In Commercial Distribution

  • 04059163000408 ()
40620061

  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Accessory Battery
VAPOTHERM, INC.
43000208
In Commercial Distribution

  • 00841737104773 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Simple Manifold NIST
VAPOTHERM, INC.
43000595
In Commercial Distribution

  • 00841737104766 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Simple Manifold DISS
VAPOTHERM, INC.
43000594
In Commercial Distribution

  • 00841737104759 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Wall to Unit DISS Hose
VAPOTHERM, INC.
43000538
In Commercial Distribution

  • 00841737104742 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Support Plate
VAPOTHERM, INC.
43000570
In Commercial Distribution

  • 00841737104735 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Tank Holder
VAPOTHERM, INC.
3101591
In Commercial Distribution

  • 00841737104728 ()


  • Professional high-flow respiratory unit, humidifying, manual
Aerosol Disposable Patient Circuit, Low Flow, India Version
VAPOTHERM, INC.
PF-ADPC-LOW-IN
In Commercial Distribution

  • 10841737104701 ()
  • 00841737104704 ()


  • Professional high-flow respiratory unit, humidifying, manual
Water Bottle Adapter, India Version
VAPOTHERM, INC.
PF-WBA-IN
In Commercial Distribution

  • 00841737104582 ()
  • 10841737104589 ()


  • Professional high-flow respiratory unit, humidifying, manual
Nitric Oxide Disposable Patient Circuit, Low Flow, India Verison
VAPOTHERM, INC.
PF-NODPC-LOW-IN
In Commercial Distribution

  • 10841737104503 ()
  • 00841737104506 ()


  • Professional high-flow respiratory unit, humidifying, manual
Nitric Oxide Disposable Patient Circuit, High Flow, India Verison
VAPOTHERM, INC.
PF-NODPC-HIGH-IN
In Commercial Distribution

  • 10841737104497 ()
  • 00841737104490 ()


  • Professional high-flow respiratory unit, humidifying, manual
Disposable Patient Circuit, Low Flow, India Verison
VAPOTHERM, INC.
PF-DPC-LOW-IN
In Commercial Distribution

  • 10841737104480 ()
  • 00841737104483 ()


  • Professional high-flow respiratory unit, humidifying, manual
Disposable Patient Circuit, High Flow, India Verison
VAPOTHERM, INC.
PF-DPC-HIGH-IN
In Commercial Distribution

  • 10841737104473 ()
  • 00841737104476 ()


  • Professional high-flow respiratory unit, humidifying, manual
Aerosol Disposable Patient Circuit, High Flow, India Version
VAPOTHERM, INC.
PF-ADPC-HIGH-IN
In Commercial Distribution

  • 10841737104466 ()
  • 00841737104469 ()


  • Professional high-flow respiratory unit, humidifying, manual
1-4 Inline Filter DISS AIR Assembly, Brazil
VAPOTHERM, INC.
3000140-BR
In Commercial Distribution

  • 00841737103868 ()


  • Professional high-flow respiratory unit, humidifying, manual
1-8 Inline Filter DISS O2 Assembly, Brazil
VAPOTHERM, INC.
3000138-BR
In Commercial Distribution

  • 00841737103851 ()


  • Professional high-flow respiratory unit, humidifying, manual
PF Battery, Brazil
VAPOTHERM, INC.
3000064-BR
In Commercial Distribution

  • 00841737103844 ()


  • Professional high-flow respiratory unit, humidifying, manual
Oxygen Sensor, Brazil
VAPOTHERM, INC.
3003011-BR
In Commercial Distribution

  • 00841737103837 ()


  • Professional high-flow respiratory unit, humidifying, manual
Filter Element 5 Micron, Brazil
VAPOTHERM, INC.
3003034-BR
In Commercial Distribution

  • 10841737103827 ()
  • 00841737103820 ()


  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Water Bottle Adapter Brazil
VAPOTHERM, INC.
PF-WBA-BR
In Commercial Distribution

  • 10841737103803 ()
  • 00841737103806 ()


  • Professional high-flow respiratory unit, humidifying, manual
3003011 PF O2 Sensor, Philippines Version
VAPOTHERM, INC.
3003011-PH
In Commercial Distribution

  • 00841737103769 ()


  • Professional high-flow respiratory unit, humidifying, manual
TA-22 Brazil
VAPOTHERM, INC.
TA-22-BR
In Commercial Distribution

  • 10841737103681 ()
  • 00841737103684 ()


  • Professional high-flow respiratory unit, humidifying, manual
AAA-1 Brazil
VAPOTHERM, INC.
AAA-1-BR
In Commercial Distribution

  • 10841737103674 ()
  • 00841737103677 ()


  • Professional high-flow respiratory unit, humidifying, manual
Nitric Oxide Disposable Patient Circuit, Low Flow Brazil
VAPOTHERM, INC.
PF-NODPC-LOW-BR
In Commercial Distribution

  • 10841737103667 ()
  • 00841737103660 ()


  • Professional high-flow respiratory unit, humidifying, manual
Nitric Oxide Disposable Patient Circuit, High Flow Brazil
VAPOTHERM, INC.
PF-NODPC-HIGH-BR
In Commercial Distribution

  • 10841737103650 ()
  • 00841737103653 ()


  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Disposable Patient Circuit, High, Korea
VAPOTHERM, INC.
PF-DPC-HIGH-KR
In Commercial Distribution

  • 10841737103513 ()
  • 00841737103516 ()


  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Disposable Patient Circuit, Low, Korea
VAPOTHERM, INC.
PF-DPC-LOW-KR
In Commercial Distribution

  • 10841737103506 ()
  • 00841737103509 ()


  • Professional high-flow respiratory unit, humidifying, manual
AAA-1, India Version
VAPOTHERM, INC.
AAA-1-IN
In Commercial Distribution

  • 10841737103384 ()
  • 00841737103387 ()


  • Professional high-flow respiratory unit, humidifying, manual
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