Identity
- Trade Name
- Chartis Console FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Console has a touch-screen user interface that is easy to navigate, and a mouse or keyboard is not required. Patient assessment data can be exported to a USB flash memory device. FDA UDI
- Model / Reference
- G3 FDA UDI
- Description
- The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Console has a touch-screen user interface that is easy to navigate, and a mouse or keyboard is not required. Patient assessment data can be exported to a USB flash memory device. FDA UDI
Identifiers
- Catalog Number
- CHR-CO-100 FDA UDI
- Primary DI / UDI-DI
- M776CHRCO100 FDA UDI
- 510(k) Number
- K111764 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic spirometer, professional
Chartis Console by Pulmonx Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pulmonx Corporation
Sources (1)
- FDA UDI b777eddd-2c45-4b09-baee-f3662fde73c4 37 fields · synced Jun 8, 2026