Duns Number:962650714
Device Description: BI8504 Opaque Biosite Plus Neutral Pressure Needleless Valve w/14" Microbore Extension
Catalog Number
BI8504
Brand Name
BIOSITE/BIOSITE PLUS
Version/Model Number
BI8504
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"
Yes
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
a86c07ff-7bdf-42f8-a3a2-76a6e939b317
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 07, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-