Duns Number:801679200
Device Description: Disposable Tubing Sets, Trima Accel® LRS® Platelet, Plasma, RBC Set
Catalog Number
-
Brand Name
Trima Accel®
Version/Model Number
82406
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
GKT
Product Code Name
Separator, automated, blood cell, diagnostic
Public Device Record Key
db7664bb-af47-424d-8e08-bc942e71eebd
Public Version Date
August 09, 2022
Public Version Number
4
DI Record Publish Date
February 15, 2017
Package DI Number
35020583824066
Quantity per Package
6
Contains DI Package
05020583824065
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |