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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
Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Bone-screw internal spinal fixation system, non-sterile
Replacement canister kit and catheters for 7000-MVP
B.L.S. Systems Limited
7000-AD
In Commercial Distribution

  • B0027000AD9 ()
  • B0027000AD0 ()
  • B0027000AD2 ()
7000-AD

  • Emergency airway clearance suction pump, manual
Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
B.L.S. Systems Limited
6210-U
In Commercial Distribution

  • B0026210U7 ()
  • B0026210U0 ()
  • B0026210U9 ()

  • Child
6210-U

  • Non-rebreathing oxygen face mask
O-Mask Oxygen Mask, Child
B.L.S. Systems Limited
6210
In Commercial Distribution

  • B00262107 ()
  • B00262100 ()
  • B00262109 ()

  • Child
6210

  • Non-rebreathing oxygen face mask
Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)
B.L.S. Systems Limited
6205-U
In Commercial Distribution

  • B0026205U7 ()
  • B0026205U0 ()
  • B0026205U9 ()

  • Small Adult
6205-U

  • Non-rebreathing oxygen face mask
O-Mask Oxygen Mask, Small Adult
B.L.S. Systems Limited
6205
In Commercial Distribution

  • B00262057 ()
  • B00262050 ()
  • B00262059 ()

  • Small Adult
6205

  • Non-rebreathing oxygen face mask
Rescuer O-Mask with Universal Tubing (Large Adult)
B.L.S. Systems Limited
6200-U
In Commercial Distribution

  • B0026200U0 ()
  • B0026200U7 ()
  • B0026200U9 ()

  • Large Adult
6200-U

  • Non-rebreathing oxygen face mask
O-Mask Oxygen Mask, Large Adult
B.L.S. Systems Limited
6200
In Commercial Distribution

  • B00262007 ()
  • B00262000 ()
  • B00262009 ()

  • Large Adult
6200

  • Non-rebreathing oxygen face mask
Rescuer Flo2Max Oxygen Mask with Universal Tubing, Child
B.L.S. Systems Limited
6110-U
In Commercial Distribution

  • B0026110U7 ()
  • B0026110U0 ()
  • B0026110U9 ()

  • Child
6110-U

  • Non-rebreathing oxygen face mask
Rescuer Flo2Max Oxygen Mask with Universal tubing, Small Adult
B.L.S. Systems Limited
6105-U
In Commercial Distribution

  • B0026105U7 ()
  • B0026105U0 ()
  • B0026105U9 ()

  • Small Adult
6105-U

  • Non-rebreathing oxygen face mask
Flo2Max 5-in-1 Oxygen Mask, Adult Small
B.L.S. Systems Limited
6105
In Commercial Distribution

  • B00261057 ()
  • B00261050 ()
  • B00261059 ()

  • Small Adult
6105

  • Non-rebreathing oxygen face mask
Rescuer Flo2Max Oxygen Mask with Universal Tubing, Large Adult
B.L.S. Systems Limited
6100
In Commercial Distribution

  • B0026100U7 ()
  • B0026100U0 ()
  • B0026100U9 ()

  • Large Adult
6100-U

  • Non-rebreathing oxygen face mask
Flo2Max 5-in-1 Oxygen Mask, Large Adult
B.L.S. Systems Limited
6100
In Commercial Distribution

  • B00261007 ()
  • B00261000 ()
  • B00261009 ()

  • Adult Large
6100

  • Non-rebreathing oxygen face mask
Rescuer disposable adult manual resuscitator with pressure release valve, 2900 mL reservoir, #5 cushion mask and 2 m crush proof oxygen tubing
B.L.S. Systems Limited
4050
In Commercial Distribution

  • B00240506 ()
  • B00240500 ()
  • B00240501 ()

  • Adult
4050

  • Pulmonary resuscitator, manual, single-use
Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 cushion mask and 2 m crush proof oxygen tubing.
B.L.S. Systems Limited
4025
In Commercial Distribution

  • B00240256 ()
  • B00240250 ()
  • B00240251 ()

  • Infant
4025

  • Pulmonary resuscitator, manual, single-use
Rescuer Child Size manual resuscitator with 2900 mL reservoir, #3 cushion mask and 2 m crush proof oxygen tubing (each)
B.L.S. Systems Limited
4010
In Commercial Distribution

  • B00240100 ()
  • B00240106 ()
  • B00240101 ()

  • Child
4010

  • Pulmonary resuscitator, manual, single-use
Disposable PEEP valve for use on the Rescuer manual resuscitator.
B.L.S. Systems Limited
4000-PEEP
In Commercial Distribution

  • B0024000PEEP3 ()
  • B0024000PEEP0 ()
  • B0024000PEEP2 ()
4000-PEEP

  • PEEP valve, single-use
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