BD Totalys™ SlidePrep Consumables Kit 491308

GUDID 00382904913083

BD Totalys™ SlidePrep Consumables Kit

TRIPATH IMAGING, INC.

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Primary Device ID00382904913083
NIH Device Record Keyff7e47e4-1a86-4c78-9cfd-ec434f9fcb96
Commercial Distribution Discontinuation2020-10-29
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Totalys™ SlidePrep Consumables Kit
Version Model Number491308
Catalog Number491308
Company DUNS103318015
Company NameTRIPATH IMAGING, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904913083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKQProcessor, Cervical Cytology Slide, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-05
Device Publish Date2016-06-23

Devices Manufactured by TRIPATH IMAGING, INC.

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10382904905269 - Rovers ® Combo-brush® 2019-04-05 Rovers ® Cervex-Brush® Combi
10382904912533 - BD SurePath™ Collection Vial Kit 5002019-04-05 BD SurePath™ Collection Vial Kit 500: BD SurePath™ Collection Vials (500)
30382904913244 - BD SurePath™ Collection Vial Kit 252019-04-05 BD SurePath™ Collection Vial Kit 25
30382904913299 - BD Settling Chambers2019-04-05 BD Settling Chambers (96). Consumables for use on the PrepStain instrument.
30382904913305 - BD Settling Chambers2019-04-05 BD Settling Chambers
00382904912475 - BD SurePath2019-04-05 BD SurePath™ GYN Cytology Test Kit
00382904913069 - BD Density Reagent2019-04-05 BD Density Reagent (1900mL)

Trademark Results [BD Totalys]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BD TOTALYS
BD TOTALYS
86839210 5210228 Live/Registered
Becton, Dickinson and Company
2015-12-04
BD TOTALYS
BD TOTALYS
85598678 not registered Dead/Abandoned
Becton, Dickinson and Company
2012-04-16

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