BD BBL™ GC II Agar with IsoVitaleX™ Enrichment 221240

GUDID 30382902212400

BD BBL™ GC II Agar with IsoVitaleX™ Enrichment, Pkg. of 8 plates (150 x 15 mm-style)

BECTON, DICKINSON AND COMPANY

Fastidious-microorganism antimicrobial susceptibility culture medium IVD

• Primary Device ID: 30382902212400
• NIH Device Record Key: 2babbdd2-d69c-4dac-ba47-e1d0e0ebccf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD BBL™ GC II Agar with IsoVitaleX™ Enrichment
• Version Model Number: 221240
• Catalog Number: 221240
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 4
• 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
• 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

• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter
• Outer Diameter: 150 Millimeter
• Depth: 15 Millimeter

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	00382902212409 [Unit of Use]
GS1	10382902212406 [Primary]
GS1	30382902212400 [Package]; Contains: 10382902212406; Package: Shelfpack [2 Units]; In Commercial Distribution
GS1	60382902212401 [Package]; Package: US pallet [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945569

FDA Product Code

• JSO: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

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: 2024-08-16
• Device Publish Date: 2016-12-21

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