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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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Blood pump PU valves; 10 mL in/out; Ø 6 mm
Berlin Heart GmbH
P10P-001
In Commercial Distribution

  • 04260090040102 ()

  • Total Volume: 10 Milliliter


  • External ventricular circulatory assist system
Blood pump PU valves; 50 mL in/out; Ø 12 mm
Berlin Heart GmbH
P50P-001
In Commercial Distribution

  • 04260090040010 ()

  • Total Volume: 50 Milliliter


  • External ventricular circulatory assist system
4.1 Software
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-7101-410
In Commercial Distribution

  • 00191506007546 ()


  • Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
493241
In Commercial Distribution

  • 04035479188733 ()
493241

  • Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
487878
In Commercial Distribution

  • 04035479185817 ()
487878

  • Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
MyHomeStream 2100.U
In Commercial Distribution

  • 04035479177416 ()
469255

  • Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
HomeStreamCP 2100.U
In Commercial Distribution

  • 04035479177409 ()
469254

  • Implantable electrical stimulation device management software
Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
2501
In Commercial Distribution

  • 10810005340035 ()
2501

  • Implantable incontinence-control electrical stimulation system programmer, line-powered
Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
1501
In Commercial Distribution

  • 10810005340028 ()
1501

  • Implantable incontinence-control electrical stimulation system programmer, line-powered
Defibrillator ,MAIN, MNL-1, 3/5LEAD,BLUETOOTH,ETCO2,SPO2,BIPHASIC,AC,PC,EL,RC,SM,CM, ENG
Zoll Medical Corporation
40010311110123010
In Commercial Distribution

  • 00847946003999 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
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