CoSense ETCO Monitor

GUDID 00858481006017

A reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.

CAPNIA, INC.

Carbon monoxide breath analyser

• Primary Device ID: 00858481006017
• NIH Device Record Key: e8926e64-7d01-4f3b-9235-190f7d386781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoSense ETCO Monitor
• Version Model Number: C20112
• Company DUNS: 030593896
• Company Name: CAPNIA, 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: true
• 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

Customer Support Contacts

• Phone: 6502138444
• Email: bhyatt@capnia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858481006017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121768

FDA Product Code

• CCJ: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14