Catalog Number
-
Brand Name
Vida
Version/Model Number
BT005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
FRI
Product Code Name
Scale, Stand-On, Patient
Public Device Record Key
6edd80f9-532a-4632-a729-45ec1815ab5e
Public Version Date
July 14, 2020
Public Version Number
1
DI Record Publish Date
July 06, 2020
Package DI Number
B726BT005V1
Quantity per Package
1
Contains DI Package
B726BT005V0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Individual box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |