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Chartis Precision Catheter

FDA UDI

Class II (US FDA UDI)

by Pulmonx Corporation

Identity

Trade Name
Chartis Precision Catheter FDA UDI
Generic Name
Bronchial balloon catheter FDA UDI
Device Name
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. FDA UDI
Model / Reference
G4 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
CHR-CA-15.0 FDA UDI
Primary DI / UDI-DI
00811907031925 FDA UDI
FDA Product Code
CBI FDA UDI
GMDN Term
Bronchial balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5740 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Working Length — 72 Centimeter FDA UDI
Balloon Diameter — 13 Millimeter FDA UDI
Length — 145 Centimeter FDA UDI

Category: Bronchial balloon catheter

Chartis Precision Catheter by Pulmonx Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bronchial balloon catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pulmonx Corporation

Sources (1)

  • FDA UDI 96d992c2-6acc-4411-8097-e1901768cfa7 37 fields · synced Jun 8, 2026