BD PrepMate™ Automated Accessory 491103

GUDID 00382904911034

BD PrepMate™ Automated Accessory (100-240V)

BECTON, DICKINSON AND COMPANY

Tissue processor IVD, automated

• Primary Device ID: 00382904911034
• NIH Device Record Key: 3e676f48-29e1-450a-b600-ea19378a6b04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD PrepMate™ Automated Accessory
• Version Model Number: 491103
• Catalog Number: 491103
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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
• 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
• 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

• Height: 21 Inch
• Height: 21 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Width: 12.5 Inch
• Height: 21 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 Inch
• Depth: 23 Inch
• Height: 22 Inch
• Width: 14 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• 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	00382904911034 [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: 2019-06-25
• Device Publish Date: 2017-09-08

On-Brand Devices [BD PrepMate™ Automated Accessory ]

• 00382904912574: BD PrepMate™ Automated Accessory Refurbished (100-240V)
• 00382904911034: BD PrepMate™ Automated Accessory (100-240V)