BD FocalPoint Slide Profiler 491464

GUDID 00382904914646

BD FocalPoint Slide Profiler (RoHS, Universal Voltage)

BECTON, DICKINSON AND COMPANY

Cell morphology analyser IVD, manual

• Primary Device ID: 00382904914646
• NIH Device Record Key: 839a9021-0200-47d5-918d-c36b3b20763d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD FocalPoint Slide Profiler
• Version Model Number: 491464
• Catalog Number: 491464
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904914646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950009

FDA Product Code

• MNM: READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-12-03

Devices Manufactured by BECTON, DICKINSON AND COMPANY

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• 00382906666574 - Horizon: 2025-02-14 BD Horizon™ Anti-TCRg/d -1 (11F2) BV421
• 00382906666444 - N/A: 2025-02-12 BD® CD24 (ML5) PE
• 00382906666451 - N/A: 2025-02-12 BD® Anti-Human IgD (IA6-2) PerCP-Cy5.5
• 00382906666468 - N/A: 2025-02-12 BD® CD13 (WM15) PerCP-Cy5.5
• 00382906666499 - N/A: 2025-02-12 BD® CD28 (L293) APC-H7
• 00382906666505 - Horizon: 2025-02-12 BD Horizon™ CD45RA (HI100) BV510
• 00382906666512 - Horizon: 2025-02-12 BD Horizon™ CD45RA (HI100) BV605