CapMedic®

Basic Information

• Brand Name: CapMedic®
• Primary DI: 00860003953709
• Version / Model: CAPMED-C
• Company Name: Cognita Labs, LLC
• Labeler DUNS: 079152829
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-08
• Public Version: 3
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: fe47fab2-a31c-4bd9-b5ec-b8a30d7be95f

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	868.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61866	Inhaler dose sensor	A small, non-sterile, battery-powered device intended to be attached to a portable inhaler [e.g., metered dose inhaler (MDI), dry powder inhaler (DPI), soft mist inhaler (SMI)] to detect when a dose of inhaled medication has been taken, and to transmit this data wirelessly to a separate device (e.g., smartphone with appropriate software) to evaluate dosing interval. It is typically used in conjunction with software that may, e.g., set reminders. This is a single-patient reusable device.	No	Active
13680	Diagnostic spirometer, professional	An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003953709	GS1