BD BACTEC™ MGIT™ 320 System 441743

GUDID 00382904417437

BD BACTEC™ MGIT™ 320 System

BECTON, DICKINSON AND COMPANY

Blood culture analyser IVD, automated

• Primary Device ID: 00382904417437
• NIH Device Record Key: 5b5eba16-9c8f-47f3-83c9-7cf639128b64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD BACTEC™ MGIT™ 320 System
• Version Model Number: 441743
• Catalog Number: 441743
• 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
• 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 Dimensions

• Height: 25 Inch
• Height: 25 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch
• Width: 36 Inch
• Depth: 28.5 Inch
• Height: 25 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 19 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904417437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974883

FDA Product Code

• MDB: SYSTEM, BLOOD CULTURING

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-25

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