BD Phoenix™ NMIC-311 449452

GUDID 00382904494520

BD Phoenix™ NMIC-311

BECTON, DICKINSON AND COMPANY

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

• Primary Device ID: 00382904494520
• NIH Device Record Key: 738b8263-e38a-49d5-b347-5874040e1c1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Phoenix™ NMIC-311
• Version Model Number: 449452
• Catalog Number: 449452
• 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
• 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
• 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	00382904494520 [Unit of Use]
GS1	30382904494521 [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: 2024-09-06
• Device Publish Date: 2024-08-29

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 30382903059301 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 12.7mm, 29G, 1mL
• 50382903059329 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 12.7mm, 29G, 0.5mL
• 50382903059343 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 8mm, 30G, 0.5mL
• 30382903059356 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 12.7mm, 29G, 0.3mL
• 30382903059370 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 8mm, 31G, 0.3mL
• 50382903284462 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 6mm, 31G, 1mL
• 50382903284479 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 6mm, 31G, 0.5mL
• 30382903284499 - SafetyGlide Insulin Syringe: 2025-05-19 SafetyGlide™ Insulin Syringes, U-100, 6mm, 31G, 0.3mL, 0.5 unit