BD BBL™ Sensi-Disc™ Ertapenem - 10 µg 232174

GUDID 00382902321743

BD BBL™ Sensi-Disc™ Ertapenem - 10 µg

BECTON, DICKINSON AND COMPANY

Multiple antibacterial susceptibility profile kit IVD Multiple antibacterial susceptibility profile kit IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD Antibacterial susceptibility testing disc IVD

• Primary Device ID: 00382902321743
• NIH Device Record Key: f10ccfe8-6fc6-490f-a23b-0a1f0fa6076b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD BBL™ Sensi-Disc™ Ertapenem - 10 µg
• Version Model Number: 232174
• Catalog Number: 232174
• 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: 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
• 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 -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382902321743 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020842

FDA Product Code

• JTN: SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-19

On-Brand Devices [BD BBL™ Sensi-Disc™ Ertapenem - 10 µg]

• 00382902321743: BD BBL™ Sensi-Disc™ Ertapenem - 10 µg
• 30382902321751: BD BBL™ Sensi-Disc™ Ertapenem - 10 µg