Catalog Number
V-707377
Brand Name
Vyaire
Version/Model Number
V-707377
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
K181524
Product Code
BZC
Product Code Name
Calculator, Pulmonary Function Data
Public Device Record Key
2ddc6d10-360e-47c1-9899-a757f59577ed
Public Version Date
March 16, 2021
Public Version Number
2
DI Record Publish Date
July 03, 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 | 76 |
2 | A medical device with a moderate to high risk that requires special controls. | 416 |