Duns Number:357007657
Device Description: Continuous ventilator
Catalog Number
202000
Brand Name
Breas Vivo 30 System
Version/Model Number
US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 16, 2021
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
-
Product Code
MNS
Product Code Name
Ventilator, Continuous, Non-Life-Supporting
Public Device Record Key
8e510617-52d5-4c41-aad7-1eee40c24e9e
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
07321822020162
Quantity per Package
1
Contains DI Package
07321822020001
Package Discontinue Date
December 16, 2021
Package Status
Not 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 |