FDA.reportPublic FDA data

Pulmonx Chartis Tablet Console

Primary DI
00811907031123
Brand
Pulmonx Chartis Tablet Console
Company
PULMONX CORPORATION
Model
CHR-CO-300
Device description
The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.
Published
2018-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180011000Pulmonx Chartis Tablet ConsolePulmonx Corporation2018-07-13BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811907031123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811907031123008119070311238119070311230811907031123

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerA mains electricity (AC-powered) device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-300-4550USCustomerService@pulmonx.com

Regulatory Flags#

DUNS number
958582595
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811907031925Chartis Precision CatheterG4CHR-CA-15.02024-03-15
00811907031819Lung Image AnalysisLIA-01-0012022-09-05
00811907031161Pulmonx Chartis Tablet ConsoleCHR-CO-3002021-04-20
M776CHRCO100Chartis ConsoleG3CHR-CO-1002016-03-25
00811907030423Zephyr Endobronchial ValveEBV-TS-5.5-LP2019-08-23
00811907031222Zephyr Delivery CatheterEDC-TS-5.5-DM2019-08-23
00811907030928Chartis CatheterG3CHR-CA-12.02018-10-03
00811907030126Zephyr Endobronchial ValveEBV-TS-4.02018-07-20
00811907030225Zephyr Endobronchial ValveEBV-TS-4.0-LP2018-07-20
00811907030324Zephyr Endobronchial ValveEBV-TS-5.52018-07-20
00811907030522Zephyr Delivery CatheterEDC-TS-4.02018-07-20
00811907030621Zephyr Delivery CatheterEDC-TS-4.0-J2018-07-20
00811907030720Zephyr Delivery CatheterEDC-TS-5.52018-07-20
M776CHRCA120Chartis CatheterG3CHR-CA-12.02016-03-25

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