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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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Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.
Mfb Fertility, Inc.
Confirm
In Commercial Distribution

  • 00860002790817 ()


  • Natural conception assistance kit
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 700
In Commercial Distribution

  • 00860002736037 ()
Provider 700

  • Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 790
In Commercial Distribution

  • 00860002736020 ()
Provider 790

  • Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
Provider 680
In Commercial Distribution

  • 00860002736013 ()
Provider 680

  • Nurse call system
No Description
JERON ELECTRONIC SYSTEMS, INC.
ProAlert 570
In Commercial Distribution

  • 00860002736006 ()
ProAlert 570

  • Nurse call system
Fukuda Denshi USA, Inc. Spot check Vital Signs Monitor
FUKUDA DENSHI USA, INC.
Fukuda VSM
In Commercial Distribution

  • 00860002604404 ()


  • General-purpose multi-parameter bedside monitor
No Description
Luminance Medical Ventures Incorporated
TN1927D
In Commercial Distribution

  • 00860002593036 ()


  • Red/blue light phototherapy unit
iWALK3.0 is a assistive mobility device most accurately described as a hands free crutch. It acts as a temporary lower leg orthotic or prosthetic and provides hands free mobility for non-weight bearing lower leg injuries. It recruits the uninjured upper leg of the user to provide ambulation.
IWALK FREE
HFC30303
In Commercial Distribution

  • 00860002590813 ()


  • Single-side-support walking frame
  • Forearm support crutch
  • Axillary crutch
Blood Collection Tube Holder
MAVERIC MEDICAL LLC
M6002
In Commercial Distribution

  • 00860002576633 ()
  • 10860002576630 ()
  • 20860002576637 ()


  • Blood collection set, invasive
Occlusion Disc, Silicone
GRI MEDICAL PRODUCTS INC
OD-1
In Commercial Distribution

  • 00860002476155 ()
OD-1

  • Gravity enema set
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