BD FocalPoint™ GS Review Station 490189

GUDID 00382904901899

BD FocalPoint™ GS Review Station Computer

BECTON, DICKINSON AND COMPANY

Cell morphology analyser IVD, manual

• Primary Device ID: 00382904901899
• NIH Device Record Key: 46aa5b73-5556-483e-ad3d-15e069e7d18a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD FocalPoint™ GS Review Station
• Version Model Number: 490189
• Catalog Number: 490189
• 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
• 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

• Length: 59.2 Centimeter
• Length: 59.2 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter
• Height: 33.2 Centimeter
• Width: 55 Centimeter
• Length: 59.2 Centimeter

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
• 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	00382904901899 [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: 2017-09-08

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