Chartis Precision Catheter CHR-CA-15.0

GUDID 00811907031925

The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Precision Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Precision Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Precision Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Precision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the Chartis Console.

PULMONX CORPORATION

Bronchial balloon catheter
Primary Device ID00811907031925
NIH Device Record Key96d992c2-6acc-4411-8097-e1901768cfa7
Commercial Distribution StatusIn Commercial Distribution
Brand NameChartis Precision Catheter
Version Model NumberG4
Catalog NumberCHR-CA-15.0
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Dimensions

Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter
Catheter Working Length72 Centimeter
Balloon Diameter13 Millimeter
Length145 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a clean and dry environment.

Device Identifiers

Device Issuing AgencyDevice ID
GS100811907031925 [Primary]

FDA Product Code

CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-25
Device Publish Date2024-03-15

Devices Manufactured by PULMONX CORPORATION

00811907031925 - Chartis Precision Catheter2024-03-25The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Precision Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Precision Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Precision Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Precision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the Chartis Console.
00811907031925 - Chartis Precision Catheter2024-03-25 The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a
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