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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Zoll Circulation, Inc.
IC-4593
In Commercial Distribution

  • 00849111050050 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 9.3 French


  • Intravascular core temperature regulation system catheter
The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Zoll Circulation, Inc.
IC-3893
In Commercial Distribution

  • 00849111050043 ()

  • Length: 38 Centimeter
  • Catheter Gauge: 9.3 French
8700-0657-03

  • Intravascular core temperature regulation system catheter
Quick Pressure Monitor set (6/pk Chamber and side ported needle)
C2DX, INC.
0295-004-000J
In Commercial Distribution

  • 00850007350192 ()
  • 20850007350042 ()


  • Compartmental-pressure monitoring system, single-use
DreamWear Under the Nose Nasal Mask, Small Medium Cushion, Large Frame, with Headgear, Japan
Respironics, Inc.
DreamWear Under Nose Mask, SM , L Frame w/Headgr, JP
Not in Commercial Distribution

  • 00606959040496 ()
1127814

  • CPAP/BPAP nasal mask, reusable
DreamWear Under the Nose Nasal Mask, Small Medium Cushion, Small Frame with Headgear, Japan
Respironics, Inc.
DreamWear Under Nose Mask, SM, S Frame w/Headgr, JP
Not in Commercial Distribution

  • 00606959040472 ()
1127812

  • CPAP/BPAP nasal mask, reusable
De Mayo D2® Knee Positioner® 30" for Japan (803-114- BP, 803-AB & 713-717)
Innovative Medical Products, Inc
803-114-NP
In Commercial Distribution

  • 00696588007076 ()
803-114-NP

  • Leg procedure positioner
De Mayo D2® Knee Positioner® 25" for Japan (803-114-S BP, 803-AB & 713-717)
Innovative Medical Products, Inc
803-114-SNP
In Commercial Distribution

  • 00696588006543 ()
803-114-SNP

  • Leg procedure positioner
AF541 Nasal Mask - Under the Nose Cushion, with Standard Elbow, with Capstrap - Extra Small, Japan
Respironics, Inc.
AF541 Mask with SE, Under the Nose, Capstrap, Size XS, JP
Not in Commercial Distribution

  • 30606959041340 ()
  • 00606959041349 ()
1129538

  • CPAP/BPAP face mask, single-use
AF541 Under the Nose Mask with Entrainment Elbow, Leak 2 with Capstrap, Size B, Japan
Respironics, Inc.
AF541Mask EE, Leak 2, Under the Nose, w/Capstrap, Size B, JP
Not in Commercial Distribution

  • 30606959041265 ()
  • 00606959041264 ()
1129499

  • CPAP/BPAP face mask, single-use
AF541 Under the Nose Mask with Entrainment Elbow, Leak 1, with Capstrap, Size C, Japan
Respironics, Inc.
AF541Mask EE, Leak 1, Under the Nose, w/Capstrap, Size C, JP
Not in Commercial Distribution

  • 30606959041241 ()
  • 00606959041240 ()
1129385

  • CPAP/BPAP face mask, single-use
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