COSMED

Basic Information

• Brand Name: COSMED
• Primary DI: 18052400180522
• Version / Model: Q-NRG
• Company Name: C O S M E D SRL
• Labeler DUNS: 438896136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-13
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 5e064a9d-645d-4512-aa90-f1bce8fa47c3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	868.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46876	Indirect calorimeter	An electrically-powered device primarily intended to measure oxygen consumption (VO2) and/or carbon dioxide output (VCO2) to estimate resting energy expenditure (REE) and/or resting metabolic rate (RMR), typically for weight loss/maintenance and nutritional assessments. It is intended to be used with a face mask, mouthpiece and/or head hood into which the patient breathes, and includes a display, controls, and connection ports. It is used in healthcare or research settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18052400180522	GS1

Premarket Submissions

Submission Number	Supplement Number
K190800	000