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 Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer Cytology specimen container IVD, transport buffer

Primary Device ID	10382904905276
NIH Device Record Key	50727383-baaf-4989-b37b-20ddaef70346
Commercial Distribution Status	In Commercial Distribution
Brand Name	SurePath Preservative Fluid Collection Vial
Version Model Number	490527
Catalog Number	490527
Company DUNS	122561087
Company Name	BECTON, DICKINSON AND COMPANY
Device Count	25
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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
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

Device Dimensions

Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter
Width	44.2 Centimeter
Length	44.2 Centimeter
Height	8.3 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904905279 [Unit of Use]
GS1	10382904905276 [Primary]
GS1	30382904905270 [Package] Package: Shelf Pack [20 Units]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P970018

FDA Product Code

MKQ	Processor, Cervical Cytology Slide, Automated

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-04-05
Device Publish Date	2017-09-08

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