DEVICE: BD Totalys SlidePrep (00382904913465)
Device Identifier (DI) Information
BD Totalys SlidePrep
491346
In Commercial Distribution
491346
BECTON, DICKINSON AND COMPANY
491346
In Commercial Distribution
491346
BECTON, DICKINSON AND COMPANY
BD Totalys SlidePrep
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? |
|---|---|---|---|---|
| 37974 | Microscope slide maker/stainer IVD |
An electrically-powered automated or semi-automated 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MKQ | Processor, Cervical Cytology Slide, Automated |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| P970018 | 030 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
a37bfa43-3704-4a93-868f-77debeec45ee
April 25, 2025
6
August 25, 2016
April 25, 2025
6
August 25, 2016
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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(800)638-8663
Technical_Services@bd.com
Technical_Services@bd.com