BD SurePath 491247

GUDID 00382904912475

BD SurePath™ GYN Cytology Test Kit

TRIPATH IMAGING, INC.

Papanicolaou smear kit

• Primary Device ID: 00382904912475
• NIH Device Record Key: 08bc10ba-4194-4407-bd75-42756dfbc8d8
• Commercial Distribution Discontinuation: 2017-09-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BD SurePath
• Version Model Number: 491247
• Catalog Number: 491247
• Company DUNS: 103318015
• Company Name: TRIPATH IMAGING, INC.
• 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

Device Dimensions

• Length: 59 Centimeter
• Length: 59 Centimeter
• Length: 59 Centimeter
• Height: 43 Centimeter
• Width: 35 Centimeter
• Length: 59 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904912475 [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: 4
• Public Version Date: 2019-04-05
• Device Publish Date: 2017-09-08

On-Brand Devices [BD SurePath]

• 00382904912475: BD SurePath™ GYN Cytology Test Kit
• 00382904905415: SurePath® Slide Library Kit
• 00382904905408: SurePath® GYN Collection Kit contains 100 collection vials used to preserve, transport, and sto
• 00382904905071: SurePath® Preservative Fluid
• 30382904905225: SurePath® GYN Preservative Vial Kit
• 30382904905119: SurePath® PreCoat Slides