FDA.reportPublic FDA data

CapMedic®

Primary DI
00860003953709
Brand
CapMedic®
Company
Cognita Labs, LLC
Model
CAPMED-C
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.
Published
2021-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZKSpirometer, Monitoring (W/Wo Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183586000CapMedicCognita Labs, LLC2019-09-13CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003953709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003953709008600039537098600039537090860003953709

GMDN Terms#

Term, Definition table
TermDefinition
Inhaler dose sensorA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079152829
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003953716PulmoScanPulmoScan-FOT2021-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZK2026-04-15
00851540007161ExSpiron Pediatric PadSetsSenzime AB (Publ.)BZK2024-01-25
05065016557004KoKoKOKO PFT LTDBZK2023-08-01
05065016557011KoKoKOKO PFT LTDBZK2023-08-01
05065016557028KoKoKOKO PFT LTDBZK2023-08-01
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBZK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyBZK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyBZK2023-04-19
00195278524089NAGE Healthcare Finland OyBZK2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyBZK2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyBZK2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyBZK2022-05-13
00840682104135NAGE Healthcare Finland OyBZK2022-03-07
00840682104302NAGE Healthcare Finland OyBZK2022-03-07
B005001450AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001460AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001470AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001490AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005001930AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002900AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002940AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002950AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002960AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002980AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005002990AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003010AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003020AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003030AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003050AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003060AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31