Duns Number:315654579
Device Description: Y-Type Blood Component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Y-Type Blood Component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path
Catalog Number
4C2161
Brand Name
Fenwal Y-Type Blood Comp. Recipient Set with Std. Blood Filter and Luer Adapter
Version/Model Number
4C2161
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
K073339,K073339
Product Code
BRZ
Product Code Name
Set, Blood Transfusion
Public Device Record Key
df54ff23-302b-4972-8cee-062148d061b1
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
March 26, 2018
Package DI Number
14052682004190
Quantity per Package
48
Contains DI Package
04052682004193
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |