FDA.reportPublic FDA data

Chartis Console

Primary DI
M776CHRCO100
Brand
Chartis Console
Company
PULMONX CORPORATION
Model
G3
Catalog number
CHR-CO-100
Device description
The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Console has a touch-screen user interface that is easy to navigate, and a mouse or keyboard is not required. Patient assessment data can be exported to a USB flash memory device.
Published
2016-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K111764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111764000CHARTIS CONSOLEPulmonx, Inc.2011-11-10BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M776CHRCO100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerAn electrically-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 Humidity5 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-216-0165lsimmonds@pulmonx.com
650-364-0400customerservice@pulmonx.com

Regulatory Flags#

DUNS number
958582595
Device count
1
Serial number
true
Manufacturing date on label
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
00811907031123Pulmonx Chartis Tablet ConsoleCHR-CO-3002018-07-20
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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