Pulmonx Chartis Tablet Console

GUDID 00811907031161

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, professional

• Primary Device ID: 00811907031161
• NIH Device Record Key: 4cf6d80c-9094-4f5a-917a-185505a3b912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulmonx Chartis Tablet Console
• Version Model Number: CHR-CO-300
• Company DUNS: 958582595
• Company Name: PULMONX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811907031161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180011

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-08
• Device Publish Date: 2021-04-20

On-Brand Devices [Pulmonx Chartis Tablet Console]

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