COSMED

GUDID 18052400180041

The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic

C O S M E D SRL

Diagnostic spirometer

• Primary Device ID: 18052400180041
• NIH Device Record Key: 6928c285-d79f-4f80-9b6d-7c1e057c9a60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COSMED
• Version Model Number: Pony FX
• Company DUNS: 438896136
• Company Name: C O S M E D SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it
• Phone: +39069315492
• Email: support@cosmed.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18052400180041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040549

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [COSMED]

• 18052400180485: K5
• 18052400180379: The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory devi
• 18052400180362: This device is intended for use in clinical and research application to measure oxygen uptake.
• 18052400180355: The COSMED Quark Series system Is a modular system with multiple configurations, allowing the fo
• 18052400180287: The Quark T12x is an ECG system that is intended to disclose either normal condition or patterns
• 18052400180263: The Quark C12x is a System for ECG and Stress Electrocardiography testing. ECG is intended to di
• 18052400180249: This device is intended for use in clinical and research application to measure oxygen uptake.
• 18052400180225: This device is intended for use in clinical and research application to measure oxygen uptake. F
• 18052400180201: The device is intended for use in clinical and research application to measure oxygen uptake. Fi
• 18052400180188: The COSMED Quark Series system Is a modular system with multiple configurations, allowing the fo
• 18052400180171: The COSMED Quark Series system Is a modular system with multiple configurations, allowing the fo
• 18052400180164: The COSMED Quark Series system Is a modular system with multiple configurations, allowing the fo
• 18052400180157: The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitoring of cardioresp
• 18052400180126: The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitoring of cardioresp
• 18052400180096: The COSMED Spiropalm pulmonary function testing systems are spirometers for performing the basic
• 18052400180072: The COSMED Spiropalm pulmonary function testing systems are spirometers for performing the basic
• 18052400180065: The COSMED Quark Series system Is a modular system with multiple configurations, allowing the fo
• 18052400180058: The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory devi
• 18052400180041: The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory devi
• 18052400180034: The COSMED microQuark pulmonary function testing system is a modular laboratory device for perfo
• 18052400180539: Q-NRG+
• 18052400180522: Q-NRG