ROTEM® 555502

GUDID 04260160470600

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

Multiple coagulation factor IVD, kit, clotting

• Primary Device ID: 04260160470600
• NIH Device Record Key: faff162e-7205-4ae9-bd57-420e56177cbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROTEM®
• Version Model Number: sigma complete + hep
• Catalog Number: 555502
• Company DUNS: 506692297
• Company Name: Tem Innovations GmbH
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260160470327 [Primary]
GS1	04260160470600 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201440

FDA Product Code

• JPA: System, Multipurpose For In Vitro Coagulation Studies

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-12
• Device Publish Date: 2022-10-04

On-Brand Devices [ROTEM®]

• 04260160470587: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470242: The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation
• 04260160470112: ROTROL P is a quality control material for monitoring accuracy and precision of tests carried ou
• 04260160470105: ROTROL N is a quality control material for monitoring accuracy and precision of tests carried ou
• 04260160470099: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470082: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470075: The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboel
• 04260160470068: The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboela
• 04260160470044: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470020: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470372: The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
• 04260160470624: The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
• 04260160470617: The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
• 04260160470600: The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i