Duns Number:315654579
Device Description: For the collection, storage, and shipment of plasma prior to fractionation. Sterile Fluid For the collection, storage, and shipment of plasma prior to fractionation. Sterile Fluid Path.
Catalog Number
6R2069
Brand Name
PLASMALINK Bottle, 1000 mL with Locking Luer Adapter
Version/Model Number
6R2069
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
BK080033,BK080033
Product Code
KSR
Product Code Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Public Device Record Key
a4fc6d9b-43fb-4088-bdb0-9b610e66de0a
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 05, 2016
Package DI Number
14086000100349
Quantity per Package
12
Contains DI Package
04086000100342
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |