AccessGUDID - DEVICE: BD FocalPoint (00382904910853)

GUDID

Device Identifier (DI) Information

Brand Name: BD FocalPoint
Version or Model: 491085
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 491085
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904910853
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: 05c96c26-2d9f-4391-ae24-ba3f28cf1dc9
Public Version Date: April 25, 2025
Public Version Number: 6
DI Record Publish Date: July 22, 2015