Pulmonx Chartis Tablet Console

GUDID 00811907031123

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.

PULMONX CORPORATION

Diagnostic spirometer
Primary Device ID00811907031123
NIH Device Record Key11612092-122b-4ec4-8520-e89c201e5dd2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulmonx Chartis Tablet Console
Version Model NumberCHR-CO-300
Company DUNS958582595
Company NamePULMONX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100811907031123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-20
Device Publish Date2018-07-20

On-Brand Devices [Pulmonx Chartis Tablet Console]

00811907031123The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer a
00811907031161The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer a

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