AccessGUDID - DEVICE: COSMED (18052400180225)

GUDID

Device Identifier (DI) Information

Brand Name: COSMED
Version or Model: Fitmate Pro
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: C O S M E D SRL

Primary DI Number: 18052400180225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438896136 *Terms of Use

Device Description: This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate Pro is designed for the measurement of Resting Metabolic Rate and maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36146	Cardiopulmonary stress exercise monitoring system	An assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZL	Computer, Oxygen-Uptake

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071533	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6be59187-37ca-4e78-b96d-382c6605ff10
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016