DEVICE: COSMED (18052400180164)
Device Identifier (DI) Information
COSMED
Quark PFT
In Commercial Distribution
C O S M E D SRL
Quark PFT
In Commercial Distribution
C O S M E D SRL
The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35282 | Pulmonary function analysis system, adult |
A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].
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FDA Product Code
[?]Product Code | Product Code Name |
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BTY | Calculator, Predicted Values, Pulmonary Function |
CBK | Ventilator, Continuous, Facility Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K120146 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a88b97b9-c1f5-4eb3-bef3-5da39ef4b4b9
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+39069315492
support@cosmed.it
support@cosmed.it