AccessGUDID - DEVICE: Microlife (00810445030001)

GUDID

Device Identifier (DI) Information

Brand Name: Microlife
Version or Model: MedGem
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICROLIFE USA, INC.

Primary DI Number: 00810445030001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176387785 *Terms of Use

Device Description: MedGem is an indirect calorimeter, which is intended to measure oxygen uptake for measurement of patient resting metabolic rate (RMR).

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZL	Computer, Oxygen-Uptake

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: abaf0d84-b7ac-4333-8342-5bc278bce15f
Public Version Date: June 22, 2023
Public Version Number: 1
DI Record Publish Date: June 14, 2023