AWARE

GUDID 00850893007002

AMBIENT CLINICAL ANALYTICS, INC.

Clinical management support software

• Primary Device ID: 00850893007002
• NIH Device Record Key: e8121220-40ac-41db-8346-170d2b40bd44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AWARE
• Version Model Number: 1.1
• Company DUNS: 080221585
• Company Name: AMBIENT CLINICAL ANALYTICS, 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
GS1	00850893007002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143372

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-07-26

On-Brand Devices [AWARE]

• 00850893007019: Clinical decision support software indicated for use by licensed clinicians in a clinical settin
• 00850893007002: 1.1