Duns Number:794519020
Device Description: Transfer Pack Container 600 mL with 8 couplers. Sterile Fluid Path
Catalog Number
4R2027
Brand Name
Transfer Pack
Version/Model Number
4R2027
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 24, 2019
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
f3b7136a-6f38-4898-bb92-6e952bf18f31
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 12, 2016
Package DI Number
10811137010735
Quantity per Package
48
Contains DI Package
00811137010738
Package Discontinue Date
January 24, 2019
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 |