PulmoScan

GUDID 00860003953716

PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometry. Bluetooth connectivity allows remote monitoring and visualization on mobile devices.

Cognita Labs, LLC

Pulmonary function analysis system, adult

• Primary Device ID: 00860003953716
• NIH Device Record Key: d5b92833-19c1-41f0-bff3-4832d65d6d43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PulmoScan
• Version Model Number: PulmoScan-FOT
• Company DUNS: 079152829
• Company Name: Cognita Labs, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003953716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191876

FDA Product Code

• PNV: Impedance Measuring Device Utilizing Oscillation Techniques

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-16
• Device Publish Date: 2021-03-08

Devices Manufactured by Cognita Labs, LLC

• 00860003953709 - CapMedic®: 2021-03-16 CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected devi
• 00860003953716 - PulmoScan: 2021-03-16PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometry. Bluetooth connectivity allows remote monitoring and visualization on mobile devices.
• 00860003953716 - PulmoScan: 2021-03-16 PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometr