NMIC-315 449085

GUDID 00382904490850

BD Phoenix™ NMIC-315

BECTON, DICKINSON AND COMPANY

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent

• Primary Device ID: 00382904490850
• NIH Device Record Key: 692f86e6-9821-4a62-a475-4da3c59f10f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NMIC-315
• Version Model Number: 449085
• Catalog Number: 449085
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 25
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904490850 [Unit of Use]
GS1	30382904490851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020322

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: 2026-02-06
• Device Publish Date: 2026-01-29

Devices Manufactured by BECTON, DICKINSON AND COMPANY

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• 30382903836483 - Nexiva: 2026-02-25 BD Nexiva™ Closed IV Catheter System 20GA x 1.75IN (Dual Port w/Cap)
• 30382903810124 - Insyte Autoguard: 2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 24 GA x 0.75 IN
• 30382903810230 - Insyte Autoguard: 2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 22 GA x 1.00 IN
• 30382903810247 - Insyte Autoguard: 2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 22 GA x 1.25 IN
• 30382903810339 - Insyte Autoguard: 2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.00 IN
• 30382903810346 - Insyte Autoguard: 2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.16 IN
• 30382903810377 - Insyte Autoguard: 2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.88 IN