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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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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
NeoPAP Bonnet - L
CIRCADIANCE, LLC
1078538
In Commercial Distribution

  • B0361074086 ()
  • B0361078538 ()
1078538

  • Neonatal CPAP unit
NeoPAP Bonnet - M
CIRCADIANCE, LLC
1078537
In Commercial Distribution

  • B0361074085 ()
  • B0361078537 ()
1078537

  • Neonatal CPAP unit
NeoPAP Bonnet - S
CIRCADIANCE, LLC
1078536
In Commercial Distribution

  • B0361074084 ()
  • B0361078536 ()
1078536

  • Neonatal CPAP unit
NeoPAP Bonnet - XS
CIRCADIANCE, LLC
1078535
In Commercial Distribution

  • B0361074083 ()
  • B0361078535 ()
1078535

  • Neonatal CPAP unit
SleepWeaver 3D Mask and Large Headgear - Blue
CIRCADIANCE, LLC
101491
In Commercial Distribution

  • B036101544 ()
  • B036101491 ()
101491

  • CPAP/BPAP nasal mask, reusable
SleepWeaver 3D Mask and Regular Headgear - Blue
CIRCADIANCE, LLC
101486
In Commercial Distribution

  • B036101539 ()
  • B036101486 ()
101486

  • CPAP/BPAP nasal mask, reusable
The AngelĀ® Catheter combines the functions of a retrievable inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC).
BIO2 MEDICAL INC
AC3930A
In Commercial Distribution

  • B077AC3930A1 ()
  • B077AC3930A5 ()


  • Vena cava filter, temporary/permanent
  • Centrally-inserted central venous catheter
27mm x 12mm x 8mm Curved TLIF with Inserter and Tamp
XENCO MEDICAL LLC
XM-011-2708
In Commercial Distribution

  • B064XM01127081 ()
  • B064XM1000001 ()


  • Spinal fixation plate, non-bioabsorbable
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