Catalog Number
V-707389
Brand Name
Vyaire
Version/Model Number
V-707389
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
K190853
Product Code
BTY
Product Code Name
Calculator, Predicted Values, Pulmonary Function
Public Device Record Key
322f47fb-6c09-4589-a925-8e81428edb58
Public Version Date
April 09, 2021
Public Version Number
1
DI Record Publish Date
April 01, 2021
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 | 76 |
2 | A medical device with a moderate to high risk that requires special controls. | 416 |