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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 Class Implantable

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The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
Tem Innovations GmbH
sigma
The BCS Cuvette Rotor is part of the BCS-XP system.
Siemens Healthcare Diagnostics Products GmbH
10446524
Behring Coagulation Cup serves as vessel for samples, human plasma and buffer solutions.
Siemens Healthcare Diagnostics Products GmbH
10446526
TEG 6S UNIT PACK
HAEMONETICS CORPORATION
07-690-US
DISPOSABLE CUPS & PINS, CLEAR
HAEMONETICS CORPORATION
6211
Reusable SpO2 Sensor/Philips/大号Soft finger cover/Adult/3.0M/087/Tracelogix Corporation
Unimed Medical Supplies, Inc.
TL122113A300B-CA652
No Description
TCOAG IRELAND LIMITED
N04000
No Description
TCOAG IRELAND LIMITED
G05000
No Description
DIAGNOSTICA STAGO
58230
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)
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