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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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No Description
Coloplast A/S
16733
In Commercial Distribution

  • 05708932718929 ()
  • 05708932718912 ()
  • 05701780135863 ()

  • Base Plate Precut Start Hole Size - mm 10
  • Base Plate Max Cut Size - mm 43
  • Descriptive Bag Size Maxi
  • Base Plate Type Convex Light
  • Base Plate Precut Start Hole Size - in 3/8
  • Base Plate Max Cut Size - in 1 11/16
16733

  • One-piece intestinal ostomy bag, open-ended
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
No Description
Coloplast A/S
11499
In Commercial Distribution

  • 05708932718882 ()
  • 05708932718875 ()
  • 05701780071048 ()

  • Coupling Size Diameter - in 2 3/8
  • Descriptive Bag Size Maxi
  • Lumen/Inner Diameter: 60 Millimeter
11499

  • Multiple-piece urostomy bag, open-ended
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.13
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
Brava Protective Seal. Feel Secure. Ostomy Care. Thickness 4.2 mm, Diameter Inner 18 mm, Diameter Inner 3/4 in, Diameter Outer 57 mm, Diameter Outer 2 1/4 in.
Coloplast A/S
12046
In Commercial Distribution

  • 05708932410229 ()
  • 05708932409421 ()
  • 05708932715737 ()

  • Lumen/Inner Diameter: 18 Millimeter
  • Outer Diameter: 57 Millimeter
  • Diameter Inner - in 3/4
  • Diameter Outer - in 2 1/4
  • Thickness - mm 4.2
12046

  • Peristomal/periwound dressing
Brava Protective Seal. Feel Secure. Ostomy Care. Thickness 2.5 mm, Diameter Inner 18 mm, Diameter Inner 3/4 in, Diameter Outer 57 mm, Diameter Outer 2 1/4 in.
Coloplast A/S
12036
In Commercial Distribution

  • 05708932409452 ()
  • 05708932715720 ()
  • 05708932409438 ()

  • Thickness - mm 2.5
  • Lumen/Inner Diameter: 18 Millimeter
  • Diameter Inner - in 3/4
  • Outer Diameter: 57 Millimeter
  • Diameter Outer - in 2 1/4
12036

  • Peristomal/periwound dressing
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.10
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
No Description
Coloplast A/S
QB5555
In Commercial Distribution

  • 05708932714068 ()
QB5555

  • Corpus cavernosum dilator, reusable
Powered Dermabrasion Device
EMAGE MEDICAL LLC
CP3
In Commercial Distribution

  • 00860012651009 ()


  • Multi-modality skin surface treatment system
Lung Isolation (Emergency Airway) Convenience Kit - Right - 39 Fr
SIMPLE SOLUTIONS MEDICAL
LIT-39-R
In Commercial Distribution

  • 00860012609376 ()


  • Endobronchial tube
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