Duns Number:357007657
Device Description: Continuous, Ventilator, Home Use
Catalog Number
215000
Brand Name
Vivo 50
Version/Model Number
US
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
K123144,K123144,K123144,K123144
Product Code
NOU
Product Code Name
Continuous, Ventilator, Home Use
Public Device Record Key
19271437-6270-457c-a94e-252a5f6d2daf
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
October 07, 2015
Package DI Number
07321822155161
Quantity per Package
1
Contains DI Package
07321822150005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |