BD BACTEC™ Myco/F Lytic Culture Vials 442288

GUDID 00382904422882

BD BACTEC™ Myco/F Lytic Culture Vials

BECTON, DICKINSON AND COMPANY

Culture medium antimicrobial supplement IVD

• Primary Device ID: 00382904422882
• NIH Device Record Key: f407c887-cae9-43f3-b49f-c7d06ae2dbc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD BACTEC™ Myco/F Lytic Culture Vials
• Version Model Number: 442288
• Catalog Number: 442288
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904422882 [Primary]
GS1	30382904422883 [Package]; Package: Shelfpack [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970333

FDA Product Code

• MDB: System, blood culturing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-05-15
• Device Publish Date: 2025-02-07

On-Brand Devices [BD BACTEC™ Myco/F Lytic Culture Vials]

• 60382904422884: BD BACTEC™ Myco/F Lytic Culture Vials
• 00382904422882: BD BACTEC™ Myco/F Lytic Culture Vials
• 30382904427949: BD BACTEC™ Myco/F Lytic Culture Vials, case of 50 vials