SurePath Preservative Fluid Collection Vial 490527

GUDID 10382904905276

SurePath® GYN Preservative Vial Kit: 10 mL SurePath® Preservative Fluid Collection Vials (500)

BECTON, DICKINSON AND COMPANY

Cytology specimen container IVD, transport buffer
Primary Device ID10382904905276
NIH Device Record Key50727383-baaf-4989-b37b-20ddaef70346
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurePath Preservative Fluid Collection Vial
Version Model Number490527
Catalog Number490527
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count25
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
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
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

Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 Centimeter
Width44.2 Centimeter
Length44.2 Centimeter
Height8.3 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
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
GS100382904905279 [Unit of Use]
GS110382904905276 [Primary]
GS130382904905270 [Package]
Package: Shelf Pack [20 Units]

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 Number5
Public Version Date2019-04-05
Device Publish Date2017-09-08

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