BD Totalys™ SlidePrep Consumables Kit 491308

GUDID 00382904913083

BD Totalys™ SlidePrep Consumables Kit

TRIPATH IMAGING, INC.

Papanicolaou smear kit

• Primary Device ID: 00382904913083
• NIH Device Record Key: ff7e47e4-1a86-4c78-9cfd-ec434f9fcb96
• Commercial Distribution Discontinuation: 2020-10-29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Totalys™ SlidePrep Consumables Kit
• Version Model Number: 491308
• Catalog Number: 491308
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904913083 [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: 2016-06-23

Devices Manufactured by TRIPATH IMAGING, INC.

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• 10382904905269 - Rovers ® Combo-brush®: 2019-04-05 Rovers ® Cervex-Brush® Combi
• 10382904912533 - BD SurePath™ Collection Vial Kit 500: 2019-04-05 BD SurePath™ Collection Vial Kit 500: BD SurePath™ Collection Vials (500)
• 30382904913244 - BD SurePath™ Collection Vial Kit 25: 2019-04-05 BD SurePath™ Collection Vial Kit 25
• 30382904913299 - BD Settling Chambers: 2019-04-05 BD Settling Chambers (96). Consumables for use on the PrepStain instrument.
• 30382904913305 - BD Settling Chambers: 2019-04-05 BD Settling Chambers
• 00382904912475 - BD SurePath: 2019-04-05 BD SurePath™ GYN Cytology Test Kit
• 00382904913069 - BD Density Reagent: 2019-04-05 BD Density Reagent (1900mL)