BD PrepStain Slide Processor 490410

GUDID 00382904904104

BD PrepMate™ Automated Accessory (115V)

TRIPATH IMAGING, INC.

Papanicolaou smear kit

• Primary Device ID: 00382904904104
• NIH Device Record Key: f43f8681-634d-4020-9264-a5e7d4f0769d
• Commercial Distribution Discontinuation: 2017-05-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BD PrepStain Slide Processor
• Version Model Number: 490410
• Catalog Number: 490410
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

• Height: 21 Inch
• Height: 21 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904904104 [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 PrepStain Slide Processor]

• 00382904909857: BD PrepMate™ Instrument 115 v (Refurbished)
• 00382904904104: BD PrepMate™ Automated Accessory (115V)
• 00382904901042: BD PrepMate™ Automated Accessory(220V)