Duns Number:794519020
Device Description: Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
Catalog Number
4R2004
Brand Name
Transfer Pack
Version/Model Number
4R2004
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
-
Product Code
KSR
Product Code Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Public Device Record Key
4b452a8b-9ab8-4ead-b1dc-ba82ae4aa9f3
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
20811137010626
Quantity per Package
8
Contains DI Package
10811137010629
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |