Cerner CareAware Event Management

Basic Information

• Brand Name: Cerner CareAware Event Management
• Primary DI: 00853023006111
• Version / Model: CareAwareEventManagement5
• Company Name: Cerner Corporation
• Labeler DUNS: 042410688
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: d5ae8452-98a2-47cf-bb9e-d488ec7699fb

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSX	System,Network And Communication,Physiological Monitors	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59378	Bedside physiologic monitoring software	An application software program intended to collect real-time patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] from a bedside monitor(s) to facilitate patient data management and communication, and may notify clinicians of events, patients at risk, or manage workflows; it is not intended for intraoperative/intraprocedural monitoring and is neither dedicated to neonatal nor obstetrical monitoring.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853023006111	GS1

Premarket Submissions

Submission Number	Supplement Number
K151672	000