AWARE DART

Basic Information

• Brand Name: AWARE DART
• Primary DI: 00850893007026
• Version / Model: 1.1
• Company Name: AMBIENT CLINICAL ANALYTICS, INC.
• Labeler DUNS: 080221585
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-26
• Public Version: 8
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 5b69457d-301c-422e-852e-965e1208ab21

Device Description

Clinical decision support software for disease detection and response indicated for use by licensed clinicians in a clinical setting.

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
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61087	Clinical management support software	An application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Otherwise known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850893007026	GS1

Premarket Submissions

Submission Number	Supplement Number
K143372	000