Duns Number:029062325
Device Description: 600mL Bag with Needle Adapter AUTOLOGOUS TRANSFER SETS
Catalog Number
C605
Brand Name
N/A
Version/Model Number
C605
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
BK960043,BK960043,BK960043
Product Code
KSR
Product Code Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Public Device Record Key
342880cf-e8eb-4aac-acaf-d4276924274c
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
00817827025556
Quantity per Package
4
Contains DI Package
00817827025051
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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. | 75 |
| U | Unclassified | 7 |