Duns Number:058027475
Device Description: Bifurcated Blood Set with 3 Gang Stopcock Manifold. Needlefree & SpinLock
Catalog Number
-
Brand Name
Warlus
Version/Model Number
B 8006-W
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"
Yes
For Single-Use
Yes
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
5b1b5dea-e339-4738-8b40-3043dcb881d9
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
813153021651
Quantity per Package
1
Contains DI Package
10813153021658
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 381 |