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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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Atrial cannula Ø 12 mm; L 33 cm; head 22 mm
Berlin Heart GmbH
C22V-002
In Commercial Distribution

  • 04260090040232 ()

  • Lumen/Inner Diameter: 12 Millimeter


  • External ventricular circulatory assist system
Arterial cannula Ø 12 mm; L 33 cm; angle 85°
Berlin Heart GmbH
C85G-002
In Commercial Distribution

  • 04260090040188 ()

  • Lumen/Inner Diameter: 12 Millimeter


  • External ventricular circulatory assist system
Cannula extension set Ø 9/9 mm
Berlin Heart GmbH
A09-009
In Commercial Distribution

  • 04260090040171 ()

  • Lumen/Inner Diameter: 9 Millimeter


  • External ventricular circulatory assist system
Arterial cannula; Ø 12 mm; L 33 cm; angle 60°
Berlin Heart GmbH
C60G-002
In Commercial Distribution

  • 04260090040164 ()

  • Lumen/Inner Diameter: 12 Millimeter


  • External ventricular circulatory assist system
Blood pump PU valves; 15 mL in/out; Ø 9 mm
Berlin Heart GmbH
P15P-001
In Commercial Distribution

  • 04260090040157 ()

  • Total Volume: 15 Milliliter


  • External ventricular circulatory assist system
Blood pump PU valves; 30 mL in/out; Ø 9 mm
Berlin Heart GmbH
P30P-001x01
In Commercial Distribution

  • 04260090040126 ()

  • Total Volume: 30 Milliliter


  • External ventricular circulatory assist system
Arterial cannula for infants Ø 5/6 mm; L 200 mm
Berlin Heart GmbH
C80G-040m
In Commercial Distribution

  • 04260090041369 ()

  • Lumen/Inner Diameter: 6 Millimeter


  • External ventricular circulatory assist system
Stationary Driving Unit Ikus Rev. 2.1
Berlin Heart GmbH
D03I-111
In Commercial Distribution

  • 04260090040225 ()


  • External ventricular circulatory assist system
Cannula extension set; Ø 6/6 mm
Berlin Heart GmbH
A06-006
In Commercial Distribution

  • 04260090040140 ()

  • Lumen/Inner Diameter: 6 Millimeter


  • External ventricular circulatory assist system
Blood pump PU valves; 25 mL in/out; Ø 9 mm
Berlin Heart GmbH
P25P-001x01
In Commercial Distribution

  • 04260090040119 ()

  • Total Volume: 25 Milliliter


  • External ventricular circulatory assist system
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