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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