DEVICE: BD Totalys SlidePrep (00382904913465)

Device Identifier (DI) Information

BD Totalys SlidePrep
491346
In Commercial Distribution
491346
BECTON, DICKINSON AND COMPANY
00382904913465
GS1

1
122561087 *Terms of Use
BD Totalys SlidePrep
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Device Characteristics

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

GMDN

[?]

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

[?]
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 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

a37bfa43-3704-4a93-868f-77debeec45ee
July 06, 2018
3
August 25, 2016
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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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
8006388663
Technical_Services@bd.com
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