Duns Number:794519020
Device Description: Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path
Catalog Number
4R2014
Brand Name
Transfer Pack
Version/Model Number
4R2014
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 2018
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
5b91cc4c-ddec-4579-ad6a-e70f2839aa22
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 12, 2016
Package DI Number
20811137010541
Quantity per Package
8
Contains DI Package
10811137010544
Package Discontinue Date
October 24, 2018
Package Status
Not 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 |