BD Phoenix™ AP AST Indicator Solution 246006

GUDID 30382902460061

BD Phoenix™ AP AST Indicator Solution

BECTON, DICKINSON AND COMPANY

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent

• Primary Device ID: 30382902460061
• NIH Device Record Key: 01434935-d3e7-412b-8986-8902cd1e7e31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Phoenix™ AP AST Indicator Solution
• Version Model Number: 246006
• Catalog Number: 246006
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 10
• 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

Device Dimensions

• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382902460060 [Unit of Use]
GS1	30382902460061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020321

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-05-19

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 00382906651266 - N/A: 2024-05-17 BD® FoxP3 (236A/E7) PerCP-Cy5.5
• 00382904440756 - BD Onclarity™ HPV Assay Reagent Pack: 2024-05-07 Kit HPV Assay Reagent for BD COR US
• 00382906635419 - N/A: 2024-04-29 BD® CD23 (EBVCS-5) PE-Cy7
• 00382903050284 - BD Sharps Collector: 2024-04-26 SHARPS COLL 17GAL HINGE PHARWASTE
• 00382903050536 - BD Recykleen™ Sharps Collector: 2024-04-26 SHARPS COLL 3GAL RECYKLEEN PEARL
• 00382903050543 - BD Recykleen™ Sharps Collector: 2024-04-26 SHARPS COLL 3GAL RECYKLEEN RED
• 00382903050581 - BD Recykleen™ Sharps Collector: 2024-04-26 SHARPS COLL NEXT GEN 5.4QT PHARM RECYK
• 00382903050765 - BD Sharps Collector: 2024-04-26 SHARPS COLL CHEMO 3GAL YELLOW NEW CAP