BD Totalys SlidePrep 491346

GUDID 00382904913465

BD Totalys SlidePrep

BECTON, DICKINSON AND COMPANY

Microscope slide maker/stainer IVD, automated
Primary Device ID00382904913465
NIH Device Record Keya37bfa43-3704-4a93-868f-77debeec45ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Totalys SlidePrep
Version Model Number491346
Catalog Number491346
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904913465 [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 Date2016-08-25

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00382904413583 - Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays2025-08-25 Swab Male Urethral Specimen Collection
00382903059041 - BD SafetyGlide2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
00382903059058 - BD SafetyGlide2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
00382903059065 - BD SafetyGlide2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 22X1-1/2 RB
00382903059096 - BD SafetyGlide2025-08-07 SYR 3ML LL W/NDL SFTYGLD 21X1-1/2 RB TW

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