COSMED

GUDID 18052400180522

C O S M E D SRL

Indirect calorimeter, line-powered Indirect calorimeter Indirect calorimeter Indirect calorimeter Indirect calorimeter Indirect calorimeter Indirect calorimeter

• Primary Device ID: 18052400180522
• NIH Device Record Key: 5e064a9d-645d-4512-aa90-f1bce8fa47c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COSMED
• Version Model Number: Q-NRG
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18052400180522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190800

FDA Product Code

• BTY: Calculator, Predicted Values, Pulmonary Function

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-21
• Device Publish Date: 2020-02-13

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