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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 HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment.
SERIM RESEARCH CORPORATION
5167
In Commercial Distribution

  • M1745167IN2 ()
  • M17451671 ()
  • M17451672 ()
  • M17451670 ()
5167

  • Multi-parameter device tester
The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.
SERIM RESEARCH CORPORATION
05140K
In Commercial Distribution

  • M1745140K2 ()
  • M1745140K1 ()
  • M1745140K0 ()
  • M1745140D2 ()
05140K

  • Helicobacter pylori urease IVD, kit, chromogenic
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
TENS Electrodes
GF HEALTH PRODUCTS, INC.
9261
In Commercial Distribution

  • M36892613 ()
  • M36892612 ()
  • M36892611 ()


  • Transcutaneous electrical stimulation electrode, single-use
TENS Electrodes
GF HEALTH PRODUCTS, INC.
9260
In Commercial Distribution

  • M36892603 ()
  • M36892602 ()
  • M36892601 ()
  • M36892600 ()


  • Transcutaneous electrical stimulation electrode, single-use
Disposable Stethoscope
GF HEALTH PRODUCTS, INC.
722Y
In Commercial Distribution

  • M368722Y2 ()
  • M368722Y1 ()
  • M368722Y3 ()


  • Mechanical stethoscope
Disposable Stethoscope
GF HEALTH PRODUCTS, INC.
722B
In Commercial Distribution

  • M368722B2 ()
  • M368722B1 ()
  • M368722B3 ()


  • Mechanical stethoscope
Portable Ultrasonic Nebulizer
GF HEALTH PRODUCTS, INC.
6700
In Commercial Distribution

  • M36867003 ()
  • M36867002 ()
  • M36867001 ()


  • Benchtop nebulizer, non-heated
Digital Thermometer
GF HEALTH PRODUCTS, INC.
HT1857
In Commercial Distribution

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


  • Intermittent electronic patient thermometer
Digital EMS TENS Unit
GF HEALTH PRODUCTS, INC.
GF-TX5EMS
In Commercial Distribution

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


  • Analgesic transcutaneous electrical nerve stimulation system
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