DEVICE: DxH (15099590798215)

Device Identifier (DI) Information

DxH
D20332
In Commercial Distribution
D20332
Beckman Coulter, Inc.
15099590798215
GS1

20
008254708 *Terms of Use
Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slidemaker Stainers, fully automated slide preparation and staining device that smears a blood film on a slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to the blood smear on the slide. Beckman Coulter DxH Slides are intended to be used to prepare whole blood samples for histological stains and preservation of blood for microscopic evaluation.
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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?
57925 General specimen microscopy slide IVD, single-use
A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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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

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Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep Dry
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3ac0bf13-c43e-4be4-824b-4f2c9d681b5e
April 14, 2025
1
April 04, 2025
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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

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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: 05099590798218 CLOSE

Direct Marking (DM)

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

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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