Catalog Number

800810-031

Brand Name

MGC Diagnsotics

Version/Model Number

800810-031

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K061731

Product Code

BZL

Product Code Name

Computer, Oxygen-Uptake

Public Device Record Key

2c46d23b-6659-4022-8be4-a90aee61a77f

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-