DEVICE: Hematek® 3000 System (00630414596563)
Device Identifier (DI) Information
Hematek® 3000 System
10805311
In Commercial Distribution
10805311
Siemens Healthcare Diagnostics Products GmbH
10805311
In Commercial Distribution
10805311
Siemens Healthcare Diagnostics Products GmbH
The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy
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? |
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15599 | Microscope slide stainer IVD |
An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KPA | SLIDE STAINER, AUTOMATED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K771559 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a4d16695-9a08-4cbb-9fbd-1ecaa376c565
November 18, 2021
2
September 24, 2020
November 18, 2021
2
September 24, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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
[?]
+1(877)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
CONTACT@SIEMENS-HEALTHINEERS.COM