DEVICE: BD PrepStain Slide Processor (00382904901004)

Device Identifier (DI) Information

BD PrepStain Slide Processor
490100
In Commercial Distribution
490100
BECTON, DICKINSON AND COMPANY
00382904901004
GS1

1
122561087 *Terms of Use
BD PrepStain® Slide Processor transfers cell samples from the specimen tubes to settling chambers mounted to microscope slides. The instrument then automatically stains and rinses each slide.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Microscope slide maker/stainer IVD, automated A mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer or fix blood, tissue or other clinical specimens onto microscope examination slides, and then stain the 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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FDA Product Code

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Product Code Product Code Name
MKQ Processor, Cervical Cytology Slide, Automated
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970018 001
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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
Storage Environment Temperature: between 0 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Depth: 25 Inch
Width: 40 Inch
Height: 34 Inch
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Device Record Status

9c631f06-2a8f-4a18-88fd-5faf59b41e9d
July 06, 2018
3
July 22, 2015
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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
No
No
No CLOSE

Customer Contact

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1-800-638-8663
technical_services@bd.com
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