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

Inhaler dose sensor
Primary Device ID00860003953709
NIH Device Record Keyfe47fab2-a31c-4bd9-b5ec-b8a30d7be95f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapMedic®
Version Model NumberCAPMED-C
Company DUNS079152829
Company NameCognita Labs, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003953709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZKSpirometer, Monitoring (W/Wo Alarm)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-16
Device Publish Date2021-03-08

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 - PulmoScan2021-03-16 PulmoScan is a portable wireless respiratory mechanics (resistance and reactance) measurement device based on Forced Oscillometr

Trademark Results [CapMedic]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPMEDIC
CAPMEDIC
86820667 5885618 Live/Registered
Cognita Labs, LLC
2015-11-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.