NMIC-312 449082

GUDID 00382904490829

NMIC-312

BECTON, DICKINSON AND COMPANY

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

• Primary Device ID: 00382904490829
• NIH Device Record Key: e831534d-24e6-473a-9fe3-b3696fc5626f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NMIC-312
• Version Model Number: 449082
• Catalog Number: 449082
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904490829 [Unit of Use]
GS1	30382904490820 [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: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 00382904449575 - BDXpert™ System: 2025-03-28 BDXpert™ System
• 00382904490829 - NMIC-312: 2025-03-28NMIC-312
• 00382904490829 - NMIC-312: 2025-03-28 NMIC-312
• 00382904490836 - NMIC/ID-313: 2025-03-28 NMIC/ID-313
• 00382906666482 - N/A: 2025-03-27 BD® CD26 (M-A261) APC
• 50382903041423 - N/A: 2025-03-25 NEEDLE 23GA 1-1/2IN BNS TW
• 30382903884378 - BD Insyte Vialon-E 20GA: 2025-03-25 INSYTE VIALON-E 20GA X 1.88IN
• 00382902411154 - BD Francisella tularensis Antigen: 2025-03-11 Vial Francisella Tularensis Antigen 5 Ml
• 00382902411161 - BD Francisella tularensis Antisera: 2025-03-11 Vial F Tularensis Antiserum