AirStrip ONE

GUDID B15320100

AirStrip Patient Monitoring - Client Web

Airstrip Technologies, Inc.

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• Primary Device ID: B15320100
• NIH Device Record Key: eedb9f86-d31f-4488-8473-55fd9d3f4609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirStrip ONE
• Version Model Number: 2010
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B15320100 [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: 4
• Public Version Date: 2018-10-17
• Device Publish Date: 2017-10-09

On-Brand Devices [AirStrip ONE ]

• B15320100: AirStrip Patient Monitoring - Client Web
• B15320020: AirStrip Cardiology, Patient Monitoring, OB - Client Android
• B15320010: AirStrip Cardiology, Patient Monitoring and OB - Client iOS
• B15320000: AirStrip Cardiology, Patient Monitoring, OB - Server Platform