FDA.reportPublic FDA data

PulmoScan

Primary DI
00860003953716
Brand
PulmoScan
Company
Cognita Labs, LLC
Model
PulmoScan-FOT
Device description
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.
Published
2021-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PNVImpedance Measuring Device Utilizing Oscillation Techniques

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNVImpedance Measuring Device Utilizing Oscillation TechniquesAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191876000PulmoScanCognita Labs, LLC2020-03-18PNV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003953716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003953716008600039537168600039537160860003953716

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

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
00860003953709CapMedic®CAPMED-C2021-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540261022807Calibrated Reference Load 15 cm H2O.s/L (2 Years Edition)Thorasys Thoracic Medical Systems IncPNV2026-04-24
07540261016646tf C2 Sensor Module - clearfloThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261017117tremoflo C2 Device - clearfloThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261019470tremoflo C2 Reference Test LoadThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261020360tremoflo C2 Airwave Oscillometry System and AccessoriesThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261022333tF C2 Sensor Module Labelled - Eco BVFThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261022371tremoflo C2 Device - Yellow - VTG 28554Thorasys Thoracic Medical Systems IncPNV2025-08-06
07540261017612tf C-100 Kit Vitalograph - Clinical Trial Edition (28300)Thorasys Thoracic Medical Systems IncPNV2024-09-20
07540261020698tF Calibrated Reference Load 15cmH2O (2 Years Edition)Thorasys Thoracic Medical Systems IncPNV2024-09-20
07540261021107tremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EUThorasys Thoracic Medical Systems IncPNV2024-09-20
07540261020797tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant EditionThorasys Thoracic Medical Systems IncPNV2024-04-12
07540261010590TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/LThorasys Thoracic Medical Systems IncPNV2021-11-03
07540261019234tremoflo C-100 Airwave Oscillometry - Support ArmThorasys Thoracic Medical Systems IncPNV2021-11-03
07540261025853tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US EditionThorasys Thoracic Medical Systems IncPNV2018-07-18
07540261009860TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/LThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261013454tremoFlo US SoftwareThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261014215Clearflo PFT Filter in bagThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261015243tremoflo C-100 Airwave Oscillometry System & Accesories - US EditionThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261016400Assembly of tremoflo US software and digital user manual CDThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261013362tF C-100 Unit-ClearFlo PFT filter compatibleThorasys Thoracic Medical Systems IncPNV2018-01-12