Chartis Precision Catheter

Primary DI
00811907031925
Brand
Chartis Precision Catheter
Company
PULMONX CORPORATION
Model
G4
Catalog number
CHR-CA-15.0
Device description
The Chartis Precision Catheter is a single use, sterile, disposable device designed to be insertedinto the working channel of a standard video or fiber bronchoscope during a diagnosticbronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, thedistal tip of the Chartis Precision Catheter can be introduced through the bronchoscope directlyinto the target airway. Inflation of the compliant balloon on the distal tip of the Chartis PrecisionCatheter causes the airway to become sealed and isolated. Air can then flow out of the isolatedlung compartment into the environment only through the central lumen of the Chartis PrecisionCatheter. Assessment is accomplished by measuring air flows and pressures exiting the ChartisPrecision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the ChartisConsole.
Published
2024-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811907031925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811907031925008119070319258119070319250811907031925

GMDN Terms#

Term, Definition table
TermDefinition
Bronchial balloon catheterA sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter13Millimeter
Catheter Working Length72Centimeter
Length145Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a clean and dry environment.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
958582595
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811907031819Lung Image AnalysisLIA-01-0012022-09-05
00811907031161Pulmonx Chartis Tablet ConsoleCHR-CO-3002021-04-20
M776CHRCO100Chartis ConsoleG3CHR-CO-1002016-03-25
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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