DEVICE: FlexLab (07640172340004)
Device Identifier (DI) Information
FlexLab
FLX
In Commercial Distribution
Inpeco SA
FLX
In Commercial Distribution
Inpeco SA
The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.
The system consolidates multiple Analytical instruments into a unified workstation.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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57871 | Specimen processing instrument IVD |
An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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CEM | Electrode, Ion Specific, Potassium |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K121012 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0db7ccee-b2bd-498f-9d67-15e52943bb12
October 14, 2024
7
September 24, 2016
October 14, 2024
7
September 24, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined