DEVICE: CELLPACK DST (04987562422944)
Device Identifier (DI) Information
CELLPACK DST
BM-808-974
In Commercial Distribution
SYSMEX CORPORATION
BM-808-974
In Commercial Distribution
SYSMEX CORPORATION
CELLPACK DST is a concentrated diluent for use in Sysmex Automated Hematology Analyzers and other Sysmex devices that use diluted CELLPACK DST.
CELLPACK DST must only be used with the Reagent Preparation Units specified by Sysmex.
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? |
---|---|---|---|---|
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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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GIF | Diluent, Blood Cell |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 4 Liter |
Device Record Status
55e378f8-41e2-45a7-b757-d4575b4bed16
June 02, 2023
2
November 30, 2022
June 02, 2023
2
November 30, 2022
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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
14987562422941
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)879-7644
crc@sysmex.com
crc@sysmex.com