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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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Total Cholesterol Strips
KPI HEALTHCARE, INC.
CURO L5 Total Cholesterol Strips
In Commercial Distribution

  • 00860394001256 ()
  • 00860394001218 ()


  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Multiple physiological parameter spot-check system analyser
  • Glucose monitoring system IVD, point-of-care
  • Glucose analyser IVD, point-of-care
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, home-use
  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
CURO L5 Cholesterol and Glucose measuring system
KPI HEALTHCARE, INC.
CURO L5 CURO L5
In Commercial Distribution

  • 00860394001225 ()


  • Multiple physiological parameter spot-check system analyser
  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care
  • Glucose analyser IVD, point-of-care
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, home-use
  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
The Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.2
In Commercial Distribution

  • 00866489000098 ()
741743

  • Nucleic acid sample preparation instrument IVD, semi-automated
A digital thermometer designed to measure body temperature orally, rectally or under the arm. It has a silicon & plastic structure, a metal sensing tip and a battery-powered chip and LCD screen. It is for multiple uses.
GMB INTERNATIONAL LIMITED
001
Not in Commercial Distribution

  • 00866066000305 ()


  • Thermometer kit
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
HUMMINGBIRD MED DEVICES INC
UAC-HM-35P 3.5 fr. 32cm Polyurethane
In Commercial Distribution

  • 10865506000285 ()
  • 00865506000288 ()


  • Arterial blood sampling kit
  • Intravenous line stopcock
  • Umbilical catheter
  • Split-septum needleless valve-connector
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
HUMMINGBIRD MED DEVICES INC
UAC-HM-50S 5.0 fr. 32cm Silicone
In Commercial Distribution

  • 10865506000261 ()
  • 00865506000264 ()


  • Split-septum needleless valve-connector
  • Umbilical catheter
  • Intravenous line stopcock
  • Arterial blood sampling kit
Single Lumen, sterile, radiopaque catheter with radius tip, Hummi Micro-Draw Blood transfer Device, Micro T Split Septum T-Connector, Dual Port Device with two closed-port silicone valve
HUMMINGBIRD MED DEVICES INC
UAC-HM-35S 3.5 fr. 32cm Silicone
In Commercial Distribution

  • 10865506000230 ()
  • 00865506000233 ()


  • Split-septum needleless valve-connector
  • Umbilical catheter
  • Intravenous line stopcock
  • Arterial blood sampling kit
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 5.400
In Commercial Distribution

  • 00864037000392 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter VSP 1.000
In Commercial Distribution

  • 00864037000385 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
BWI-D
In Commercial Distribution

  • 00864037000378 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
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