Cerner CareAware Event Management

GUDID 00853023006111

CERNER CORPORATION

Bedside physiologic monitoring software

• Primary Device ID: 00853023006111
• NIH Device Record Key: d5ae8452-98a2-47cf-bb9e-d488ec7699fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerner CareAware Event Management
• Version Model Number: CareAwareEventManagement5
• Company DUNS: 042410688
• Company Name: CERNER CORPORATION
• 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
GS1	00853023006111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151672

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: 4
• Public Version Date: 2019-07-12
• Device Publish Date: 2016-09-24

On-Brand Devices [Cerner CareAware Event Management]

• 00853023006135: CareAwareEventManagement6
• 00853023006111: CareAwareEventManagement5