DEVICE: CAPILLARYS 3 DBS (03607360012444)

Device Identifier (DI) Information

CAPILLARYS 3 DBS
1244
In Commercial Distribution
1244
SEBIA
03607360012444
GS1

1
276801933 *Terms of Use
INSTRUMENT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GKA Abnormal Hemoglobin Quantitation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K232027 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bbbcf99b-b3f4-4c07-a981-91581e5f23aa
May 08, 2024
1
April 30, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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No Customer Contact currently defined
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