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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BiPAP Auto BiFlex with Heated Tube Humidifier, Standard Tube, System One 60 Series, Canada
Respironics, Inc.
BiPAP Auto BiFlex w/H Tube Humid, St Tube, 60 Srs, CA
In Commercial Distribution

  • 00606959031746 ()
CA761NTS

  • Home BPAP unit
REMstar SE Auto with Heated Humidifier and Standard Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto w/Htd Humid and St Tube, w/SD Slot, CA
In Commercial Distribution

  • 00606959036772 ()
CA521NTS

  • Home CPAP unit
  • Heated respiratory humidifier
BiPAP Pro BiFlex with Heated Tube Humidifier, Standard Tube, 60 Series, Canada
Respironics, Inc.
BiPAP Pro BiFlex, w/H Tube Hum, with St Tube, 60 Series, CA
In Commercial Distribution

  • 00606959031401 ()
CA661NTS

  • Home BPAP unit
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
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