BD BACTEC™ FX40 Instrument 442296

GUDID 00382904422967

BD BACTEC™ FX40 Instrument

BECTON, DICKINSON AND COMPANY

Blood culture analyser IVD, automated

• Primary Device ID: 00382904422967
• NIH Device Record Key: db329464-5afd-499e-aac4-09c611fd4e1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD BACTEC™ FX40 Instrument
• Version Model Number: 442296
• Catalog Number: 442296
• 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

• Width: 67.5 Centimeter
• Width: 67.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter
• Height: 39.1 Centimeter
• Depth: 58.5 Centimeter
• Width: 67.5 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904422967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915796

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

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 50382903247054 - BD Insulin Syringe: 2024-12-16 U-100 Insulin Syringe, 1.0mL, 27G x 12.7mm
• 00382902900207 - BD Sputum Collection System: 2024-11-27 BD Sputum Collection System, Case of 72 units
• 30382902461006 - BD Kiestra™ Isolate Suspension Cuvette Array: 2024-11-27 BD Kiestra™ Isolate Suspension Cuvette Array
• 50382903032780 - Eclipse Needle: 2024-11-21 NEEDLE ECLIPSE 23X1-1/2 RB TW BNS
• 60382904454755 - BD BACTEC™ 9240: 2024-11-12 BD BACTEC™ 9240
• 60382904455707 - BD BACTEC™ 9120: 2024-11-12 BD BACTEC™ 9120
• 00382904458003 - BD BACTEC™ 9050: 2024-11-11 BD BACTEC™ 9050
• 00382904454166 - BD Onclarity HPV Self Collection Diluent Tube: 2024-11-11 BD Onclarity HPV Self Collection Diluent Tube