CapMedic®

GUDID 00860003953709

CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected device can also perform PEF and FEV1 tests to track lung function.

Cognita Labs, LLC

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• Primary Device ID: 00860003953709
• NIH Device Record Key: fe47fab2-a31c-4bd9-b5ec-b8a30d7be95f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CapMedic®
• Version Model Number: CAPMED-C
• 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: true
• 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	00860003953709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183586

FDA Product Code

• BZK: Spirometer, Monitoring (W/Wo Alarm)

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®: 2021-03-16CapMedic is an interactive smart inhaler add-on that provides guidance for correct and regular use. The Bluetooth-connected device can also perform PEF and FEV1 tests to track lung function.
• 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: 2021-03-16 PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometr