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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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Foam Positioner Straps Brown Polyurethane Foam Brown CA/12 POSITIONING STRAPS Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49489
In Commercial Distribution

  • 20885632448666 ()
  • 10885632448669 ()


  • Freestanding patient positioner, single-use
Foam Positioner Extremity Blue 16X8X2 IN Polyurethane Foam Blue CA/24 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49488
In Commercial Distribution

  • 20885632448659 ()
  • 10885632448652 ()


  • Freestanding patient positioner, single-use
Foam Positioner Extremity Blue White Polyurethane Foam Blue White CA/6 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49480
In Commercial Distribution

  • 20885632448628 ()
  • 10885632448621 ()


  • Freestanding patient positioner, single-use
RAPIDLyte Multicap Capillaries (500 tubes) approx. volume 140µL. Each tube contains 130-200 I.U./mL Na+/Li+/Ca++ heparin, titrated with KCl. For capillary blood collection for the analysis of pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10311005
In Commercial Distribution

  • 00630414107622 ()
  • 00630414009261 ()
473646

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution

  • 04260160470587 ()
201001

  • Coagulation analyser IVD, laboratory, semi-automated
Bluetooth Accessory Module, Canada
Respironics, Inc.
Bluetooth Accessory Module, CA
Not in Commercial Distribution

  • 00606959005136 ()
100210B

  • Clinical laboratory information system
DreamStation BiPAP Pro, Canada
Respironics, Inc.
DreamStation BiPAP Pro, CA
In Commercial Distribution

  • 00606959026612 ()
CAX600S12

  • Home BPAP unit
DreamStation Auto CPAP, Canada
Respironics, Inc.
DreamStation Auto CPAP, CA
In Commercial Distribution

  • 00606959026582 ()
CAX500S12

  • Home CPAP unit
DreamStation CPAP Pro, Canada
Respironics, Inc.
DreamStation CPAP Pro, CA
In Commercial Distribution

  • 00606959026551 ()
CAX400S12

  • Home CPAP unit
Dorma 500 Auto, Canada
Respironics, Inc.
Dorma 500 Auto, CA
In Commercial Distribution

  • 00606959036734 ()
CAV501

  • Heated respiratory humidifier
  • Home CPAP unit
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