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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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20/20 BiDirectional PDR X-ray Machine.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR400i
In Commercial Distribution

  • 00817100020131 ()
BD715

  • Stationary basic diagnostic x-ray system, digital
MAINTENANCE MACHINE -TTBIO BRANDED XTEND AX
HANDPIECE PARTS & REPAIRS, INC.
08090012TB5
In Commercial Distribution

  • 00810988030292 ()
08090012TB5

  • Dental handpiece maintenance unit
No Description
LivaNova Deutschland GmbH
Pads Green
In Commercial Distribution

  • 34033817900635 ()
  • 04033817900634 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Pads White
In Commercial Distribution

  • 34033817900628 ()
  • 04033817900627 ()


  • Cardiopulmonary bypass system, roller type
Viz HCM v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution

  • 00811852030332 ()


  • Cardiopulmonary physiological parameter analysis software
CARDIOHELP Emergency Drive
Maquet Cardiopulmonary AG
CARDIOHELP Emergency Drive (w/o holder)
In Commercial Distribution

  • 04058863112176 ()
70107.1881

  • Cardiopulmonary bypass system, roller type
CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting the CARDIOHELP Base Plate or CARDIOHELP Wall Holder incl. CARDIOHELP protection cover.
Maquet Cardiopulmonary AG
Mobile Holder HKH 8860
Not in Commercial Distribution

  • 04058863084336 ()
70107.3079

  • Medical device rail
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-Hospital transport. The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).
Maquet Cardiopulmonary AG
CARDIOHELP-i
In Commercial Distribution

  • 04058863074863 ()
70107.2780

  • Cardiopulmonary bypass system, roller type
MAQUET CARDIOHELP Bubble Sensor BS 3/8x1/16-1/4x3/32 L1.7
Maquet Cardiopulmonary AG
BS 3/8x1/16-1/4x3/32 L1.7
Not in Commercial Distribution

  • 04037691816449 ()
70105.5721

  • Cardiopulmonary bypass system air bubble/fluid level detector
MAQUET CARDIOHELP Bubble Sensor BS 3/8x3/32 L1.7
Maquet Cardiopulmonary AG
BS 3/8x3/32 L1.7
In Commercial Distribution

  • 04037691816432 ()
70105.5720

  • Cardiopulmonary bypass system air bubble/fluid level detector
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