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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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A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
321244NS
In Commercial Distribution

  • B066321244NS3 ()
  • B066321244NS1 ()
  • B066321244NS0 ()
  • B066321244NS4 ()
321244NS

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
321223NS
In Commercial Distribution

  • B066321223NS3 ()
  • B066321223NS1 ()
  • B066321223NS0 ()
  • B066321223NS4 ()
321223NS

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
321222NS
In Commercial Distribution

  • B066321222NS3 ()
  • B066321222NS1 ()
  • B066321222NS0 ()
  • B066321222NS4 ()
321222NS

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system
SynGenX®-1000 Disposable Cartridge
Thermogenesis Corp.
SGI-0305
In Commercial Distribution

  • B039SGI03050 ()
  • B039SGI03051 ()
  • B039SGI03059 ()


  • Umbilical cord blood collection set
CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system
SUTURE, MONOFYL, 0, NFSL
American Health Service Sales Corporation
MV-Y987
In Commercial Distribution

  • B031MVY9870 ()
  • B031MVY9871 ()
  • B031MVY9872 ()


  • Poliglecaprone suture
SUTURE, MONOFYL, 0, NCP-1
American Health Service Sales Corporation
MV-Y967
In Commercial Distribution

  • B031MVY9670 ()
  • B031MVY9671 ()
  • B031MVY9672 ()


  • Poliglecaprone suture
SUTURE, MONOFYL, 2-0, NFS-1
American Health Service Sales Corporation
MV-Y943
In Commercial Distribution

  • B031MVY9430 ()
  • B031MVY9431 ()
  • B031MVY9432 ()


  • Poliglecaprone suture
SUTURE, MONOFYL, 3-0, NFS-1
American Health Service Sales Corporation
MV-Y942
In Commercial Distribution

  • B031MVY9420 ()
  • B031MVY9421 ()
  • B031MVY9422 ()


  • Poliglecaprone suture
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