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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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Serim® GUARDIAN™ Blood Leak Test Strips - M1745119C

Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.
SERIM RESEARCH CORPORATION
5119C
In Commercial Distribution

  • M1745119C2 ()
  • M1745119C ()
  • M1745119C0 ()
  • M1745119IN ()
5119C

  • Haemodialysis system blood leak detector

Health Team - M368HT18571

Digital Thermometer
GF HEALTH PRODUCTS, INC.
HT1857
In Commercial Distribution

  • M368HT18573 ()
  • M368HT18572 ()
  • M368HT18571 ()


  • Intermittent electronic patient thermometer

Grafco - M368GFTX5EMS1

Digital EMS TENS Unit
GF HEALTH PRODUCTS, INC.
GF-TX5EMS
In Commercial Distribution

  • M368GFTX5EMS3 ()
  • M368GFTX5EMS2 ()
  • M368GFTX5EMS1 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GFTX51

Digital TENS Unit
GF HEALTH PRODUCTS, INC.
GF-TX5
In Commercial Distribution

  • M368GFTX53 ()
  • M368GFTX52 ()
  • M368GFTX51 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GF451

Digital TENS Lead Wires
GF HEALTH PRODUCTS, INC.
GF-45
In Commercial Distribution

  • M368GF453 ()
  • M368GF452 ()
  • M368GF451 ()


  • Transcutaneous electrical stimulation lead

Grafco - M368GF3T1

TENS Unit, Analog
GF HEALTH PRODUCTS, INC.
GF-3T
In Commercial Distribution

  • M368GF3T3 ()
  • M368GF3T2 ()
  • M368GF3T1 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GF31

TENS Unit, Analog
GF HEALTH PRODUCTS, INC.
GF-3
In Commercial Distribution

  • M368GF33 ()
  • M368GF32 ()
  • M368GF31 ()


  • Analgesic transcutaneous electrical nerve stimulation system

LabTron - M3682221

Wallmax Aneroid Sphygmomanometer
GF HEALTH PRODUCTS, INC.
222
In Commercial Distribution

  • M3682223 ()
  • M3682222 ()
  • M3682221 ()


  • Aneroid manual sphygmomanometer

LUMISCOPE - M36822151

Digital Ear Thermometer
GF HEALTH PRODUCTS, INC.
2215
In Commercial Distribution

  • M36822153 ()
  • M36822152 ()
  • M36822151 ()


  • Intermittent electronic patient thermometer

LUMISCOPE - M3682214CE1

Digital Thermometer
GF HEALTH PRODUCTS, INC.
2214.CE
In Commercial Distribution

  • M3682214CE3 ()
  • M3682214CE2 ()
  • M3682214CE1 ()


  • Intermittent electronic patient thermometer
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