BDXpert™ System 444957

GUDID 00382904449575

BDXpert™ System

BECTON, DICKINSON AND COMPANY

Microorganism identification/antimicrobial-susceptibility analyser IVD

• Primary Device ID: 00382904449575
• NIH Device Record Key: e118f20e-8c16-4683-96b5-36ddca2ba054
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BDXpert™ System
• Version Model Number: 444957
• Catalog Number: 444957
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904449575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250344

FDA Product Code

• LON: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

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: 2025-03-28
• Device Publish Date: 2025-03-20

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• 30382903648154 - BD Vacutainer® One Use Holder: 2026-02-05 HOLDER ONE USE NONSTACKABLE
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• 50382903678438 - BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes: 2026-02-04 TUBE EDTA PLC 13X75 2.0 PLBL LAV
• 00382902451228 - BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes: 2026-01-15 BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes, 7 mL, carton of 100 tubes
• 00382903649327 - BD Vacutainer Urine Complete Cup Kit: 2026-01-13 KIT URINCOL 13x75C&S 16x100UAP 13x100UA