DEVICE: ROTEM® (04260160470105)
Device Identifier (DI) Information
ROTEM®
ROTROL N
In Commercial Distribution
503-24-US, 503-24
Tem Innovations GmbH
ROTROL N
In Commercial Distribution
503-24-US, 503-24
Tem Innovations GmbH
ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
30590 | Multiple coagulation factor IVD, control |
A material which is used to verify the performance of an assay 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JPA | System, Multipurpose For In Vitro Coagulation Studies |
GGN | Plasma, Coagulation Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K083842 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6a758e8e-bff9-499d-bbf2-f40898e7ade4
August 20, 2021
4
September 16, 2016
August 20, 2021
4
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04260160470525
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined