Duns Number:804736098
Device Description: Vios Nebulizer System, LC Sprint, custom label
Catalog Number
-
Brand Name
Vios
Version/Model Number
310F35-PC
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
K092918,K092918
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
eed1c854-1f66-4603-8a2b-82b301515f4a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
00744229311102
Quantity per Package
6
Contains DI Package
00744229310631
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 111 |