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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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System One 60 Series - 00606959031401

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 System One 60 Series - 00606959030152

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 - 08718734961499

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 - 08718734961482

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 - 08718734961475

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 Electrolyte Analyzer - 00811403019892

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

Welch Allyn, Inc. - 00732094319804

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

Welch Allyn, Inc. - 00732094319811

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 - 08718734961468

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

Green Guard Trauma Kit - 00347682119553

8213 -1.000 EACH Blood Pressure Unit Adult w/ca 8215 -1.000 EACH Labtron Stethoscope 3015 -1.000 EACH GG Alcohol Swabs (50) 6102 -1.000 EACH 2" RIP-N-WRAP 6520 - 2.000 EACH Emergency Large Wound Dressing 3302 -4.000 EACH GG Cold Pack Medium/Boxed + 6400 -2.000 EACH GG Triangular Bandage + 8200 -1.000 EACH 5 1/2" Band Scissors 8202 -1.000 EACH Paramedic Scissors 6253- 2.000 EACH Waterproof Tape 1/2" x 5yds 6254 -2.000 EACH Waterproof Tape 1"x5 yds 8060 -1.000 EACH CPR Microshield 6206 -1.000 EACH GG 3x3 Gauze Pads (25) 4106 -2.000 EACH GG 8oz Eye Wash 6314 1.000 EACH GG 1x3 Plastic Strip Bandage (60) 6115- 2.000 EACH 2" Sterile Gauze Roll 8053 -1.000 EACH Disposable Airway Assorted Sizes 1193 -1.000 EACH Trauma Kit Hard Pack (Empty) 8524 -1.000 EACH Space Blanket + 7920 -2.000 EACH Glove Wipes 6117 -2.000 EACH 3" Sterile Gauze Roll SS110 - 1.000 EACH MCR Stratos Black/Clear 8212I- 2.000 EACH Penlight Disposable - Ind.
Greenguard
1195
In Commercial Distribution

  • 50347682119558 ()
  • 00347682119553 ()
1195

  • First aid kit, medicated
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