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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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SynGenX®-1000 Control Module
Thermogenesis Corp.
SGI-0046-01
In Commercial Distribution

  • B039SGI0046010 ()
  • B039SGI0046011 ()


  • Blood component separator, automated
NeoPAP Mask - L
CIRCADIANCE, LLC
1078668
In Commercial Distribution

  • B0361074127 ()
  • B0361078668 ()
1078668

  • Neonatal CPAP unit
NeoPAP Mask - S
CIRCADIANCE, LLC
1078667
In Commercial Distribution

  • B0361078667 ()
  • B0361074125 ()
1078667

  • Neonatal CPAP unit
NeoPAP Cannula - XL
CIRCADIANCE, LLC
1078616
In Commercial Distribution

  • B0361074124 ()
  • B0361078616 ()
1078616

  • Neonatal CPAP unit
NeoPAP Cannula - L
CIRCADIANCE, LLC
1078614
In Commercial Distribution

  • B0361074123 ()
  • B0361078614 ()
1078614

  • Neonatal CPAP unit
NeoPAP Cannula - M
CIRCADIANCE, LLC
1078613
In Commercial Distribution

  • B0361074121 ()
  • B0361078613 ()
1078613

  • Neonatal CPAP unit
NeoPAP Cannula - S
CIRCADIANCE, LLC
1078612
In Commercial Distribution

  • B0361074120 ()
  • B0361078612 ()
1078612

  • Neonatal CPAP unit
NeoPAP Cannula - XS
CIRCADIANCE, LLC
1078611
In Commercial Distribution

  • B0361074119 ()
  • B0361078611 ()
1078611

  • Neonatal CPAP unit
NeoPAP Delivery Circuit Adapter & Sizing Chart
CIRCADIANCE, LLC
1078582
In Commercial Distribution

  • B0361074128 ()
  • B0361078582 ()
1078582

  • Neonatal CPAP unit
NeoPAP Bonnet - XL
CIRCADIANCE, LLC
1078539
In Commercial Distribution

  • B0361074117 ()
  • B0361078539 ()
1078539

  • Neonatal CPAP unit
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