DEVICE: BD FocalPoint (00382904910853)
Device Identifier (DI) Information
BD FocalPoint
491085
In Commercial Distribution
491085
BECTON, DICKINSON AND COMPANY
491085
In Commercial Distribution
491085
BECTON, DICKINSON AND COMPANY
BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides using a high speed video microscope, digital camera, and image interpretation software. Slide results data are presented through reports from the BD FocalPoint Workstation Computer. BD FocalPoint instrument with digital imaging system.
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? |
---|---|---|---|---|
15132 | Cell morphology analyser IVD, manual |
An electrically-powered manual laboratory instrument intended to be used for the qualitative microscopic examination of blood or other clinical specimens in order to view, count, record and evaluate the morphological characteristics of cells and other biological components. The device typically includes a microscope, camera, monitor and software package.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNM | Reader, Cervical Cytology Slide, Automated |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P950009 | 015 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 29 Inch |
Width: 33.5 Inch |
Height: 33.5 Inch |
Device Record Status
05c96c26-2d9f-4391-ae24-ba3f28cf1dc9
April 25, 2025
6
July 22, 2015
April 25, 2025
6
July 22, 2015
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