BD SurePath 491097

GUDID 00382904910976

SurePath® GYN Preservative Vial Kit with Brush/Spatula

BECTON, DICKINSON AND COMPANY

Papanicolaou smear kit

• Primary Device ID: 00382904910976
• NIH Device Record Key: 430e2cf1-40b1-420d-8670-9d85fb81b121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD SurePath
• Version Model Number: 491097
• Catalog Number: 491097
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Dimensions

• Length: 44 Centimeter
• Length: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 Centimeter
• Height: 37 Centimeter
• Width: 44 Centimeter
• Length: 44 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904910976 [Primary]

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: 2015-07-23

On-Brand Devices [BD SurePath]

• 00382904910976: SurePath® GYN Preservative Vial Kit with Brush/Spatula
• 00382904910969: SurePath® GYN Preservative Vial Kit with Cervex-Brush Combi
• 00382904910952: SurePath® GYN Preservative Vial Kit with Cervex-Brush