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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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ROTEM® - 04260160470587

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

Dorma 500 - 00606959036734

Dorma 500 Auto, Canada
Respironics, Inc.
Dorma 500 Auto, CA
In Commercial Distribution

  • 00606959036734 ()
CAV501

  • Heated respiratory humidifier
  • Home CPAP unit

MILL,10 LPM,CONC CANADIAN - 00606959033184

Millennium M10 Concentrator, Canada
Respironics, Inc.
Millennium M10 Concentrator, CA
In Commercial Distribution

  • 00606959033184 ()
M10600-80

  • Stationary oxygen concentrator

BiPAP System One 60 Series - 00606959031753

BiPAP Auto, BlueTooth, Canada
Respironics, Inc.
BiPAP Auto BlueTooth, CA
In Commercial Distribution

  • 00606959031753 ()
761CABT

  • Home BPAP unit

DreamStation - 00606959026643

DreamStation Auto BiPAP, Canada
Respironics, Inc.
DreamStation Auto BiPAP, CA
In Commercial Distribution

  • 00606959026643 ()
CAX700S12

  • Home BPAP unit

DreamStation - 00606959026612

DreamStation BiPAP Pro, Canada
Respironics, Inc.
DreamStation BiPAP Pro, CA
In Commercial Distribution

  • 00606959026612 ()
CAX600S12

  • Home BPAP unit

DreamStation - 00606959026582

DreamStation Auto CPAP, Canada
Respironics, Inc.
DreamStation Auto CPAP, CA
In Commercial Distribution

  • 00606959026582 ()
CAX500S12

  • Home CPAP unit

DreamStation - 00606959026551

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

  • 00606959026551 ()
CAX400S12

  • Home CPAP unit

BiPAP System One 60 Series - 00606959031418

BiPAP Pro, Bluetooth, Canada
Respironics, Inc.
BiPAP Pro, Bluetooth, CA
In Commercial Distribution

  • 00606959031418 ()
661CABT

  • Home BPAP unit

BiPAP A30 - 00606959039339

BiPAP A30 Ventilator, Canada
Respironics, Inc.
BiPAP A30 Ventilator, CA
In Commercial Distribution

  • 00606959039339 ()
1111147

  • Portable electric ventilator
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