DEVICE: CAPILLARYS 3 DBS (03607360012444)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
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57837 | Electrophoresis analyser IVD |
An electrically-powered automated or semi-automated laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GKA | Abnormal Hemoglobin Quantitation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K232027 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Storage Environment Humidity: between 5 and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify: Avoid contact with water_Dangerous Voltage_Do not store near magnets or magnetic devices_Fragile handle with care_Keep away from sunlight_This way up |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bbbcf99b-b3f4-4c07-a981-91581e5f23aa
May 08, 2024
1
April 30, 2024
May 08, 2024
1
April 30, 2024
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined