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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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
Precision Flow Oxygen Assist Module, DPC HIGH
VAPOTHERM, INC.
PF-OAMDPC-HIGH
In Commercial Distribution

  • 00841737103066 ()
  • 10841737103063 ()


  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Oxygen Assist Module, DPC LOW
VAPOTHERM, INC.
PF-OAMDPC-LOW
In Commercial Distribution

  • 10841737103056 ()
  • 00841737103059 ()


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

  • 10841737102981 ()
  • 00841737102984 ()


  • Professional high-flow respiratory unit, humidifying, manual
Water Bottle Adapter and Disposable Patient Circuit High Flow
VAPOTHERM, INC.
PF-DPC-High-WBA
In Commercial Distribution

  • 10841737102509 ()
  • 00841737102502 ()


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

  • 00841737102458 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT-VTU-OUS Transfer Kit
VAPOTHERM, INC.
HVT-VTU-OUS
In Commercial Distribution

  • 00841737102434 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT20-UNIT-VTU-OUS
VAPOTHERM, INC.
HVT20-UNIT-VTU-OUS
In Commercial Distribution

  • 00841737102427 ()


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

  • 10841737102417 ()
  • 00841737102410 ()


  • Professional high-flow respiratory unit, humidifying, manual
Brazil Disposable Patient Circuit HighFlow
VAPOTHERM, INC.
PF-DPC-High-BR
In Commercial Distribution

  • 10841737102394 ()
  • 00841737102397 ()


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

  • 10841737100758 ()
  • 00841737100751 ()


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

  • 10841737100734 ()
  • 00841737100737 ()


  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow
VAPOTHERM, INC.
PF-UNIT
In Commercial Distribution

  • 00841737100140 ()


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

  • 10841737100116 ()
  • 00841737100119 ()


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

  • 00841737100102 ()
  • 10841737100109 ()


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

  • 10841737100093 ()
  • 00841737100096 ()


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

  • 10841737100086 ()
  • 00841737100089 ()


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

  • 00841737105725 ()
  • 10841737105722 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Unit, VTU, OUS, Brazil Version
VAPOTHERM, INC.
HVT20-UNIT-VTU-BR
In Commercial Distribution

  • 00841737105718 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 UKIT, Brazil Version
VAPOTHERM, INC.
HVT-UKIT-BR
In Commercial Distribution

  • 00841737105701 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 VTU OUS, Brazil Version
VAPOTHERM, INC.
HVT-VTU-OUS-BR
In Commercial Distribution

  • 00841737105695 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT20-MAS-FLM
VAPOTHERM, INC.
HVT20-MAS-FLM
In Commercial Distribution

  • 00841737105688 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT20-NEL-FLM
VAPOTHERM, INC.
HVT20-NEL-FLM
In Commercial Distribution

  • 00841737105671 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT20-UNIT-FLM
VAPOTHERM, INC.
HVT20-UNIT-FLM
In Commercial Distribution

  • 00841737105664 ()


  • Professional high-flow respiratory unit, humidifying, manual
PF Plus Compliant Version, Floor Model Unit
VAPOTHERM, INC.
PF-C-PLUS-FLM
In Commercial Distribution

  • 00841737105657 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT UKIT, German Version
VAPOTHERM, INC.
HVT-UKIT-DE
In Commercial Distribution

  • 00841737105640 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT UKIT, Canada Version
VAPOTHERM, INC.
HVT-UKIT-CA
In Commercial Distribution

  • 00841737105633 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 DPC-WBA Bundled SKU
VAPOTHERM, INC.
HVT-DPC-WBA
In Commercial Distribution

  • 10841737105623 ()
  • 00841737105626 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 ADPC-WBA Bundled SKU
VAPOTHERM, INC.
HVT-ADPC-WBA
In Commercial Distribution

  • 10841737105616 ()
  • 00841737105619 ()


  • Professional high-flow respiratory unit, humidifying, manual
Air Filter Cover
VAPOTHERM, INC.
43000742
In Commercial Distribution

  • 00841737105602 ()


  • Professional high-flow respiratory unit, humidifying, manual
Carabiner
VAPOTHERM, INC.
43000741
In Commercial Distribution

  • 00841737105596 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 ADPC, High Flow
VAPOTHERM, INC.
HVT-ADPC-HIGH
In Commercial Distribution

  • 10841737105586 ()
  • 00841737105589 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 ADPC, Low Flow
VAPOTHERM, INC.
HVT-ADPC-LOW
In Commercial Distribution

  • 10841737105579 ()
  • 00841737105572 ()


  • Professional high-flow respiratory unit, humidifying, manual
Tubing Adapter for HVT/PF, 22mm
VAPOTHERM, INC.
HPF-TA-22
In Commercial Distribution

  • 10841737105562 ()
  • 00841737105565 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT UKIT, Australia Version
VAPOTHERM, INC.
HVT-UKIT-AU
In Commercial Distribution

  • 00841737105541 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT UKIT, Argentina Version
VAPOTHERM, INC.
HVT-UKIT-AR
In Commercial Distribution

  • 00841737105534 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT-UKIT-DISS-EU
VAPOTHERM, INC.
HVT-UKIT-DISS-EU
In Commercial Distribution

  • 00841737105510 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 UKIT, NIST Version
VAPOTHERM, INC.
HVT-UKIT-NIST
In Commercial Distribution

  • 00841737105473 ()


  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 UKIT, GB Version
VAPOTHERM, INC.
HVT-UKIT-GB
In Commercial Distribution

  • 00841737105466 ()


  • Professional high-flow respiratory unit, humidifying, manual
Oxygen Assist Module Nellcor, UKIT Philippines Version
VAPOTHERM, INC.
OAM-NEL-UKIT-PH
In Commercial Distribution

  • 00841737105459 ()


  • Professional high-flow respiratory unit, humidifying, manual
PF Heliox, South Africa (4th Ed)
VAPOTHERM, INC.
PFH-UKIT-C-ZA
In Commercial Distribution

  • 00841737105442 ()


  • Professional high-flow respiratory unit, humidifying, manual
Oxygen Assist Module Masimo, UKIT Philippines Version
VAPOTHERM, INC.
OAM-MAS-UKIT-PH
In Commercial Distribution

  • 00841737105435 ()


  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Aerosol Disposable Patient Circuit, Low 4
VAPOTHERM, INC.
PF-ADPC-LOW4
In Commercial Distribution

  • 00841737105428 ()


  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Aerosol Disposable Patient Circuit, High 4
VAPOTHERM, INC.
PF-ADPC-HIGH4
In Commercial Distribution

  • 00841737105404 ()


  • Professional high-flow respiratory unit, humidifying, manual
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