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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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HUMIDIFIED INSUFFLATION KIT
FISHER & PAYKEL HEALTHCARE LIMITED
ST520
In Commercial Distribution

  • 09420012433985 ()
  • 09420012433978 ()
ST520

  • Insufflation gas conditioning tubing set
HUMIDIFIER SH870 115V US
FISHER & PAYKEL HEALTHCARE LIMITED
SH870JHU
In Commercial Distribution

  • 09420012433060 ()
SH870JHU

  • Insufflation gas conditioning system control unit
The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
CHALICE MEDICAL LIMITED
CME40009
Not in Commercial Distribution

  • 15060491619817 ()
  • 05060491619810 ()
CME40009

  • Extracorporeal membrane oxygenation system circuit
The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
CHALICE MEDICAL LIMITED
CME40004
In Commercial Distribution

  • 15060491614126 ()
  • 05060491614129 ()
CME40004

  • Extracorporeal membrane oxygenation system circuit
This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (01003214) and the Spartan RX Printer (01003438).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420071 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420064 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373).
Spartan Bioscience Inc
01003374, 01003372, and 01003373
In Commercial Distribution

  • 00628055420057 ()
01003374, 01003372, and 01003373

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Barcode Scanner supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003359
In Commercial Distribution

  • 00628055420040 ()
01003359

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Printer supplied with the Spartan RX CYP2C19 System
Spartan Bioscience Inc
01003438
In Commercial Distribution

  • 00628055420033 ()
01003438

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Netbook supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003214
In Commercial Distribution

  • 00628055420026 ()
01003214

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
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