BD FocalPoint Slide Profiler Refurbished 491090

GUDID 00382904910907

BD FocalPoint Refurbished (120V)

BECTON, DICKINSON AND COMPANY

Cell morphology analyser IVD, manual

Primary Device ID	00382904910907
NIH Device Record Key	b0d8e8e8-ca82-41b6-b3b3-c28cfe5c66f3
Commercial Distribution Status	In Commercial Distribution
Brand Name	BD FocalPoint Slide Profiler Refurbished
Version Model Number	491090
Catalog Number	491090
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
Phone	+1(800)638-8663
Email	Technical_Services@BD.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature
Special Storage Condition, Specify	Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904910907 [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	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-07-05
Device Publish Date	2019-06-27

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