AccessGUDID - DEVICE: MGC Diagnostics (B368800810001)

GUDID

Device Identifier (DI) Information

Brand Name: MGC Diagnostics
Version or Model: 800810-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 800810-001
Company Name: MEDICAL GRAPHICS CORPORATION

Primary DI Number: B368800810001
Issuing Agency: HIBCC
Commercial Distribution End Date: February 22, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 094045622 *Terms of Use

Device Description: Ultima System CPX

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 [?]
K061731	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: 75771217-a8e5-4a6e-967c-41b219c08fb3
Public Version Date: August 10, 2021
Public Version Number: 4
DI Record Publish Date: September 09, 2016