BD SurePath™ PreCoat Slides 491248

GUDID 30382904912483

BD SurePath™ PreCoat Slides (96)

BECTON, DICKINSON AND COMPANY

Papanicolaou smear kit
Primary Device ID30382904912483
NIH Device Record Key9a07146b-dc85-43e6-b5e7-81824c42fe8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD SurePath™ PreCoat Slides
Version Model Number491248
Catalog Number491248
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count96
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
Phone800-638-8663
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
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 Dimensions

Width11 Centimeter
Width11 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter
Height11 Centimeter
Length22 Centimeter
Width11 Centimeter

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
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
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
GS100382904912482 [Unit of Use]
GS130382904912483 [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 Date2017-09-08

Devices Manufactured by BECTON, DICKINSON AND COMPANY

00382904449575 - BDXpert™ System2025-03-28 BDXpert™ System
00382904490829 - NMIC-3122025-03-28 NMIC-312
00382904490836 - NMIC/ID-3132025-03-28 NMIC/ID-313
00382906666482 - N/A2025-03-27 BD® CD26 (M-A261) APC
50382903041423 - N/A2025-03-25 NEEDLE 23GA 1-1/2IN BNS TW
30382903884378 - BD Insyte Vialon-E 20GA2025-03-25 INSYTE VIALON-E 20GA X 1.88IN
00382902411154 - BD Francisella tularensis Antigen2025-03-11 Vial Francisella Tularensis Antigen 5 Ml
00382902411161 - BD Francisella tularensis Antisera2025-03-11 Vial F Tularensis Antiserum

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.