DEVICE: Lumipulse G Wash Solution (04987270231173)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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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58236 | Buffered wash solution IVD |
A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142895 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: right side up with care; no vibration |
Storage Environment Temperature: between 2 and 10 Degrees Celsius |
Handling Environment Temperature: between 2 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 1000 Milliliter |
Device Record Status
ec24bf05-f5bc-4932-8711-0a9bf6b29a6d
June 02, 2023
6
September 16, 2016
June 02, 2023
6
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
610-240-3800
customersupport@fdi.com
customersupport@fdi.com