BD SurePath 490540

GUDID 00382904905408

SurePath® GYN Collection Kit contains 100 collection vials used to preserve, transport, and store cevical cytology samples.

TRIPATH IMAGING, INC.

Papanicolaou smear kit

• Primary Device ID: 00382904905408
• NIH Device Record Key: 6caa0185-1e58-45e6-82c0-cab781224d48
• Commercial Distribution Discontinuation: 2015-08-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BD SurePath
• Version Model Number: 490540
• Catalog Number: 490540
• Company DUNS: 103318015
• Company Name: TRIPATH IMAGING, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: 51.5 Centimeter
• Length: 51.5 Centimeter
• Length: 51.5 Centimeter
• Height: 32.5 Centimeter
• Width: 31.5 Centimeter
• Length: 51.5 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	00382904905408 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-22

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