DEVICE: Hematek® 3000 System (00630414596563)

Device Identifier (DI) Information

Hematek® 3000 System
10805311
In Commercial Distribution
10805311
Siemens Healthcare Diagnostics Products GmbH
00630414596563
GS1

1
388240673 *Terms of Use
The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
KPA SLIDE STAINER, AUTOMATED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K771559 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a4d16695-9a08-4cbb-9fbd-1ecaa376c565
November 18, 2021
2
September 24, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No
No CLOSE

Customer Contact

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+1(877)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
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