COSMED

GUDID 18052400180362

This device is intended for use in clinical and research application to measure oxygen uptake.

C O S M E D SRL

Indirect calorimeter, line-powered

• Primary Device ID: 18052400180362
• NIH Device Record Key: 34605285-37a4-4888-a184-8ce36c78ade7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COSMED
• Version Model Number: Fitmate GS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18052400180362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071533

FDA Product Code

• BZL: Computer, Oxygen-Uptake

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

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• 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
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• 18052400180171: The COSMED Quark Series system Is a modular system with multiple configurations, allowing the fo
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• 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
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• 18052400180539: Q-NRG+
• 18052400180522: Q-NRG