DEVICE: pocH-pack D (10664369402553)
Device Identifier (DI) Information
pocH-pack D
PPD-300A
In Commercial Distribution
SYSMEX CORPORATION
PPD-300A
In Commercial Distribution
SYSMEX CORPORATION
Diluent for the pocH-100i hematology analyzer
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 |
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 |
---|
Storage Environment Temperature: between 1 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 2 Liter |
Device Record Status
483df7b1-29ca-441f-b9b1-cc6704bd6311
June 02, 2023
2
November 04, 2022
June 02, 2023
2
November 04, 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:
80664369402552
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)879-7639
crc@sysmex.com
crc@sysmex.com