Duns Number:118112924
Catalog Number
-
Brand Name
Bivona
Version/Model Number
35W040
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
Yes
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
K792035
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
c1f9aceb-23f0-4cc6-b568-09834acbbad8
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 01, 2015
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 | 104 |
2 | A medical device with a moderate to high risk that requires special controls. | 36112 |