MGC Diagnostics - GAS DLCO RTD LINEARITY 0.35%CO, 0.35%CH4, 21%O2, - MEDICAL GRAPHICS CORPORATION

Duns Number:094045622

Device Description: GAS DLCO RTD LINEARITY 0.35%CO, 0.35%CH4, 21%O2, BAL N2

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More Product Details

Catalog Number

536563-010

Brand Name

MGC Diagnostics

Version/Model Number

536563-010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

BXK

Product Code Name

Gas, Calibration (Specified Concentration)

Device Record Status

Public Device Record Key

cdd88ca6-a91a-4ebf-9cd3-65dd89652a65

Public Version Date

April 09, 2019

Public Version Number

1

DI Record Publish Date

April 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL GRAPHICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 54
2 A medical device with a moderate to high risk that requires special controls. 105