DEVICE: BD FocalPoint (00382904910877)

Device Identifier (DI) Information

BD FocalPoint
491087
In Commercial Distribution
491087
BECTON, DICKINSON AND COMPANY
00382904910877
GS1

1
122561087 *Terms of Use
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.
CLOSE

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
Cell morphology analyser IVD, manual A mains electricity (AC-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 and operates with technician involvement in most procedural steps.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MNM Reader, Cervical Cytology Slide, Automated
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P950009 015
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 29 Inch
Width: 33.5 Inch
Height: 33.5 Inch
CLOSE

Device Record Status

e7461dca-884d-4dc7-a779-f766addfea8d
July 06, 2018
3
July 22, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
800-638-8663
technical_services@bd.com
CLOSE