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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REMstar Pro C-Flex+, Heated Tube Humidifier, Standard Tube, BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Pro C-Flex+, w/H T Hum, St Tube, BTooth, 60 Srs, CA
In Commercial Distribution

  • 00606959030206 ()
CA461NTBT

  • Home CPAP unit
REMstar Pro C-Flex+, with Heated Tube Humidifier, Standard Tube, System One 60 Series, Canada
Respironics, Inc.
REMstar Pro C-Flex+, w/H Tube Humid, w/St Tube, 60 Srs, CA
In Commercial Distribution

  • 00606959030152 ()
CA461NTS

  • Home CPAP unit
CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol B.V.
Level 3
In Commercial Distribution

  • 08718734961529 ()
  • 08718734961499 ()
221.003.010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol B.V.
Level 2
In Commercial Distribution

  • 08718734961512 ()
  • 08718734961482 ()
221.002.010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol B.V.
Level 1
In Commercial Distribution

  • 08718734961505 ()
  • 08718734961475 ()
221.001.010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. It is microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness.
Diamond Diagnostics Inc.
0-DD-SMARTLYTE
Not in Commercial Distribution

  • 00811403019892 ()


  • Ion-selective analyser IVD
Surveyor S19 GEN2 Pat Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, CO2, starter kit, resistive color touchscreen 18.5" display w/ 1366 x 768 res, AC or li-ion rechargeable battery operation; US/CA pwr cord; AHA 5 wire ECG pat cable with clip ends; Edwards invasive blood pressure cable (qty 2) and Y cable; No cardiac output cable; Ext thermal printer(w/ starter pack of thermal paper roll, 1.97 in. x 100 ft.,(50mm x 30.48m) 10 rolls); LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094319804 ()
SUR19-SAC-DXAAX

  • General-purpose multi-parameter bedside monitor
Surveyor S19 GEN2 Pat Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2/3/4, CO2, starter kit, Cardiac Output, resistive color touchscreen 18.5" display w/ 1366 x 768 res AC or lithium ion rechargeable batt operation; US/CA pwr cord; AHA 5 wire ECG pat cable w/ clip ends; Edwards invasive blood pressure cable (qty 2) and Y cable; No cardiac output cable; Ext thermal printer(w/ starter pack of thermal paper roll, 1.97 in. x 100 ft.(50mm x 30.48m) 10 rolls); LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094319811 ()
SUR19-ZAC-DXAAX

  • General-purpose multi-parameter bedside monitor
CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. A box of CueSee® VeriSTAT LVM contains 5 levels of control material: CueSee® VeriSTAT LVM Level 1 - 08718734961413 CueSee® VeriSTAT LVM Level 2 - 08718734961420 CueSee® VeriSTAT LVM Level 3 - 08718734961437 CueSee® VeriSTAT LVM Level 4 - 08718734961444 CueSee® VeriSTAT LVM Level 5 - 08718734961451
Eurotrol B.V.
220.000.005
In Commercial Distribution

  • 08718734961468 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Healqu Hydrocolloid Extra Thin Dressing 6x6
Healqu LLC
9024266
In Commercial Distribution

  • 10819143021370 ()
  • 00819143021373 ()
  • 20819143021377 ()
  • 00819143025326 ()
  • 00819143025333 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
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