Duns Number:343189676
Device Description: PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 9/24
Catalog Number
FV306T
Brand Name
PaediGAV®
Version/Model Number
FV306T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 11, 2021
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
cbf8db2d-fada-4faa-95a4-d66fbbecb03c
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 24, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 630 |