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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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Temperature Probe
MEASUREMENT SPECIALTIES, INC.
4491
In Commercial Distribution

  • H29744912 ()
  • H29744911 ()
  • H29744910 ()

  • Outer Diameter: 3 Millimeter
861527

  • General-purpose patient temperature probe, single-use
Foley Catheter Temperature Probe, 18 FR
MEASUREMENT SPECIALTIES, INC.
4468
In Commercial Distribution

  • H29744682 ()
  • H29744681 ()
  • H29744680 ()

  • Catheter Gauge: 18 French
861557

  • General-purpose patient temperature probe, single-use
Foley Catheter Temperature Probe, 16 FR
MEASUREMENT SPECIALTIES, INC.
4466
In Commercial Distribution

  • H29744660 ()
  • H29744661 ()
  • H29744662 ()

  • Catheter Gauge: 16 French
861556

  • General-purpose patient temperature probe, single-use
Foley Catheter Temperature Probe, 14 FR
MEASUREMENT SPECIALTIES, INC.
4464
In Commercial Distribution

  • H29744642 ()
  • H29744641 ()
  • H29744640 ()

  • Catheter Gauge: 14 French
861555

  • General-purpose patient temperature probe, single-use
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution

  • M729700580I1 ()
  • M729700580I0 ()
  • M729700580I3 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French


  • Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
Utopia HV Face Mask - Large
Innomed Technologies Inc
LG
In Commercial Distribution

  • M694UTO2955 ()
  • M694UTO2953 ()
  • M694UTO2951 ()
UTO295

  • CPAP/BPAP face mask, reusable
Utopia HV Face Mask - Medium
Innomed Technologies Inc
MD
In Commercial Distribution

  • M694UTO2935 ()
  • M694UTO2933 ()
  • M694UTO2931 ()
UTO293

  • CPAP/BPAP face mask, reusable
Utopia HV Face Mask - Small
Innomed Technologies Inc
SM
In Commercial Distribution

  • M694UTO2915 ()
  • M694UTO2913 ()
  • M694UTO2911 ()
UTO291

  • CPAP/BPAP face mask, reusable
Utopia NE Face Mask - Large (with Black Headgear)
Innomed Technologies Inc
LG
In Commercial Distribution

  • M694UTO275A5 ()
  • M694UTO275A3 ()
  • M694UTO275A1 ()
UTO275A

  • CPAP/BPAP face mask, single-use
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