Duns Number:831996595
Device Description: Description: 0.3% CO, 10% He, 21% O2, Bal. N2Cylinder: ED3 Valve: CGA 500For use with Pulm Description: 0.3% CO, 10% He, 21% O2, Bal. N2Cylinder: ED3 Valve: CGA 500For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
Catalog Number
Z04NI68FED0000
Brand Name
Scott Medical Products
Version/Model Number
Pulmonary Function Gas
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)
-
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
b3c00514-2e37-4f9c-8fc3-97ef6fc52f45
Public Version Date
June 10, 2019
Public Version Number
1
DI Record Publish Date
May 31, 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 | 281 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |