AirStrip ONE Web Client

GUDID B15320030

Medical Device Software Application

Airstrip Technologies, Inc.

Bedside physiologic monitoring software Bedside physiologic monitoring software Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter Bedside monitor remote-viewing software, physiological parameter

• Primary Device ID: B15320030
• NIH Device Record Key: 72ead20e-1bcc-4b0b-838a-c0b0b2ecf01c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirStrip ONE Web Client
• Version Model Number: 2003
• Company DUNS: 079232437
• Company Name: Airstrip Technologies, 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: true
• 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

Customer Support Contacts

• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com
• Phone: 1-877-258-5869
• Email: support@airstrip.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B15320030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160862

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: 2
• Public Version Date: 2018-10-17
• Device Publish Date: 2018-09-13

Devices Manufactured by Airstrip Technologies, Inc.

• B15310000 - AirStrip OB Legacy Server: 2018-10-17 OB Legacy System Server Software System
• B15310010 - AirStrip OB Legacy iOS: 2018-10-17 OB Legacy System iOS Software System
• B15320000 - AirStrip ONE: 2018-10-17 AirStrip Cardiology, Patient Monitoring, OB - Server Platform
• B15320010 - AirStrip ONE: 2018-10-17 AirStrip Cardiology, Patient Monitoring and OB - Client iOS
• B15320020 - AirStrip ONE: 2018-10-17 AirStrip Cardiology, Patient Monitoring, OB - Client Android
• B15320030 - AirStrip ONE Web Client: 2018-10-17Medical Device Software Application
• B15320030 - AirStrip ONE Web Client: 2018-10-17 Medical Device Software Application
• B15320100 - AirStrip ONE: 2018-10-17 AirStrip Patient Monitoring - Client Web