DEVICE: CELLPACK DST (04987562422944)

Device Identifier (DI) Information

CELLPACK DST
BM-808-974
In Commercial Distribution

SYSMEX CORPORATION
04987562422944
GS1

2
690664461 *Terms of Use
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.
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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?
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).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GIF Diluent, Blood Cell
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 4 Liter
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Device Record Status

55e378f8-41e2-45a7-b757-d4575b4bed16
June 02, 2023
2
November 30, 2022
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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
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Secondary DI

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

[?]
Unit of Use DI Number: 14987562422941 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888)879-7644
crc@sysmex.com
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