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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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Universal Knee Brace
HOME AIDE DIAGNOSTICS, INC.
UKBrace
In Commercial Distribution

  • 10860006377899 ()
  • 00860006377892 ()


  • Tubular support bandage, non-latex, reusable
Pure Comfort Breath Exerciser
HOME AIDE DIAGNOSTICS, INC.
7830
In Commercial Distribution

  • 10860006377837 ()
  • 00860006377830 ()


  • Incentive spirometer
Posture Corrector
HOME AIDE DIAGNOSTICS, INC.
PCorrector
In Commercial Distribution

  • 10860006377820 ()
  • 00860006377823 ()


  • Lumbar spine orthosis
No Description
Infinitus Medical Technologies LLC
FM03-IF
In Commercial Distribution

  • 00860006375942 ()
FM03-IF

  • Operating table patient positioning set, single-use
No Description
Infinitus Medical Technologies LLC
FM02-IF
In Commercial Distribution

  • 00860006375935 ()
FM02-IF

  • Operating table patient positioning set, single-use
No Description
Infinitus Medical Technologies LLC
DP-01
In Commercial Distribution

  • 00860006375928 ()
DP-01

  • Operating table patient positioning set, single-use
No Description
Infinitus Medical Technologies LLC
IONESPS-2000
In Commercial Distribution

  • 00860006375911 ()


  • Arm procedure positioner, reusable
No Description
Infinitus Medical Technologies LLC
KSSC-1000-1
In Commercial Distribution

  • 00860006375904 ()
KSSC-1000-1

  • Operating table patient positioning set, single-use
Catalyst Live is a telepresence solution that enables collaboration in imaging, surgical, remote, and hybrid environments.
Ascend Cardiovascular LLC
7.2
In Commercial Distribution

  • 00860006348007 ()


  • Video consultation telemedicine system
Lumin serves as both a general-purpose sanitizing device for personal care items (e.g. cell phone, eyeglasses, keys, etc.) as well as CPAP accessories (e.g. hose, mask, and water chamber. In terms of CPAP sanitizer, there is no requirement for sterility or disinfection for single-patient re-use of CPAP accessories in the home. Most manufacturer instructions require simple cleaning with soap and water. Lumin is intended to be used as an adjunct to following the manufacturer’s instructions for routine cleaning but provides the convenience of bioburden reduction in 5 minutes. Lumin is designed to be used only with the CPAP accessories (i.e. CPAP Mask, hose, and water chamber), and not on the CPAP machine itself.
3B MEDICAL, INC.
LM3000
In Commercial Distribution

  • 00860006339906 ()


  • Ultraviolet device disinfection chamber
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