BD FocalPoint 491085

GUDID 00382904910853

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.

BECTON, DICKINSON AND COMPANY

Cell morphology analyser IVD, manual

• Primary Device ID: 00382904910853
• NIH Device Record Key: 05c96c26-2d9f-4391-ae24-ba3f28cf1dc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD FocalPoint
• Version Model Number: 491085
• Catalog Number: 491085
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com
• Phone: +1(800)638-8663
• Email: technical_services@bd.com

Device Dimensions

• Height: 33.5 Inch
• Height: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch
• Length: 29 Inch
• Width: 33.5 Inch
• Height: 33.5 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904910853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950009

FDA Product Code

• MNM: Reader, Cervical Cytology Slide, Automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-24
• Device Publish Date: 2015-07-22

On-Brand Devices [BD FocalPoint]

• 00382904910877: BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slide
• 00382904910860: BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides
• 00382904910853: BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides