Duns Number:094045622
Device Description: GAS DLCO RTD LINEARITY 0.13%CO, 0.16%CH4, 5%CO2, 17%O2, BAL N2
Catalog Number
536563-012
Brand Name
MGC Diagnostics
Version/Model Number
536563-012
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
-
Product Code
BXK
Product Code Name
Gas, Calibration (Specified Concentration)
Public Device Record Key
c28e9369-06ce-4ef1-bc6a-26ed03d012f7
Public Version Date
April 09, 2019
Public Version Number
1
DI Record Publish Date
April 01, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |