BacterioScan 216Dx System

GUDID B9090010

System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

BACTERIOSCAN, INC.

Microbial incubator/imaging system IVD

• Primary Device ID: B9090010
• NIH Device Record Key: 84a910e9-d830-4227-b2d9-b128138efc15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BacterioScan 216Dx System
• Version Model Number: 216Dx
• Company DUNS: 029599160
• Company Name: BACTERIOSCAN, INC.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B9090010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172412

FDA Product Code

• QBQ: System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-23
• Device Publish Date: 2020-09-15

On-Brand Devices [BacterioScan 216Dx System]

• B9090010: System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
• B90900522: Case with 256 cartridges.
• B90900511: Disposable used in system
• B9090050: Single disposable - no packaging
• B9090020: Network appliance used in system