Bernoulli

GUDID 00854709006029

BERNOULLI ENTERPRISE INC.

Patient monitoring system central station monitor

• Primary Device ID: 00854709006029
• NIH Device Record Key: 52fb984b-6453-4f40-85a9-fe316474bc0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bernoulli
• Version Model Number: Bernoulli One Software
• Company DUNS: 080109729
• Company Name: BERNOULLI ENTERPRISE 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: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	00854709006029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091461

FDA Product Code

• MSX: System,Network And Communication,Physiological Monitors

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: 2017-12-05