Duns Number:831996595
Device Description: Description: 0.3% CO, 10% He, 21% O2, Bal. N2;Cylinder: ED; Valve: CGA 973;For use with Vy Description: 0.3% CO, 10% He, 21% O2, Bal. N2;Cylinder: ED; Valve: CGA 973;For use with Vyaire's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; CE Marked;Vyaire Part #: 761817;
Catalog Number
Z04NI685EDC002
Brand Name
Vyaire
Version/Model Number
Pulmonary Function Cal 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
3fad13b9-8090-41de-b2f6-ecf27eb9be27
Public Version Date
January 08, 2020
Public Version Number
1
DI Record Publish Date
December 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 |