DEVICE: Lumipulse G Specimen Diluent 1 (04987270231203)
Device Identifier (DI) Information
Lumipulse G Specimen Diluent 1
231203
In Commercial Distribution
FUJIREBIO INC.
231203
In Commercial Distribution
FUJIREBIO INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
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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? |
---|---|---|---|---|
58237 | Buffered sample diluent IVD |
A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GIF | Diluent, Blood Cell |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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: 1200 Milliliter |
Device Record Status
e3179b1b-ad6f-44a5-8488-b01729a9f0e6
June 02, 2023
4
September 16, 2016
June 02, 2023
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:
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