PulmoScan

Basic Information

• Brand Name: PulmoScan
• Primary DI: 00860003953716
• Version / Model: PulmoScan-FOT
• 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: 1
• Public Version Date: 2021-03-16
• Public Version Status: New
• Public Device Record Key: d5b92833-19c1-41f0-bff3-4832d65d6d43

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.

Device Characteristics

• Single Use: No
• 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
PNV	Impedance Measuring Device Utilizing Oscillation Techniques	Anesthesiology	868.1840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35282	Pulmonary function analysis system, adult	A 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].	No	Active
36134	Pulmonary function analysis system, paediatric	A computerized instrument designed to assess lung volume, flow, and mechanical parameters (including airway compliance and resistance) in young children and infants. It is different from an adult version in absolute dimensions and in the special procedures required for adaption to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant reclines for plethysmography, use of a pressure jacket to obtain forced exhalation); also, parameters that require subject cooperation (e.g., vital capacity, forced expiratory volume) can't be determined. The device is used for pulmonary function testing in diagnostic studies and for evaluation of diseases and chest deformities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003953716	GS1

Premarket Submissions

Submission Number	Supplement Number
K191876	000