FDA.reportPublic FDA data

ROTEM®

Primary DI
04260160470600
Brand
ROTEM®
Company
Tem Innovations GmbH
Model
sigma complete + hep
Catalog number
555502
Device description
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.
Published
2022-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JPASystem, Multipurpose For In Vitro Coagulation Studies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201440000ROTEM sigma Thromboelastometry SystemTem Innovations GmbH2022-07-08JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260160470327PrimaryGS10
04260160470600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260160470327042601604703274260160470327
04260160470600042601604706004260160470600

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen, using a clotting method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
506692297
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260160470327ROTEM®sigma complete + hep5555022022-10-04
04260160470341ROTEM®sigma ROTROL N5552012022-10-04
04260160470358ROTEM®sigma ROTROL P5552022022-10-04
04260160470044ROTEM®in-tem®503-02-US2016-09-16
04260160470068ROTEM®ap-tem®503-04-US2016-09-16
04260160470075ROTEM®fib-tem®503-06-US2016-09-16
04260160470082ROTEM®hep-tem®503-09-US2016-09-16
04260160470099ROTEM®star-tem® 20503-10-US2016-09-16
04260160470105ROTEM®ROTROL N503-24-US, 503-242016-09-16
04260160470112ROTEM®ROTROL P503-25-US, 503-252016-09-16
04260160470242ROTEM®ex-tem®503-05-US2016-09-16
04260160470617ROTEM®sigma ROTROL N5552012022-10-04
04260160470624ROTEM®sigma ROTROL P5552022022-10-04
04260160470372ROTEM®sigma2110002022-10-04
04260160470587ROTEM®delta System (US/CA)2010012018-03-15
04260160470020ROTEM®delta System200100-US2016-09-16

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Primary DI, Brand, Company table
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20763000558189CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
20763000558295RACTMEDTRONIC, INC.JPA2026-02-22
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08430793058322HemosIL CL Probe ConditionerINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
10812747018531Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
20812747018538Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
00630414639772Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
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