Duns Number:006261481
Device Description: FILTER 351T TRILL AFFINITY
Catalog Number
-
Brand Name
TRILLIUM® Affinity®
Version/Model Number
351T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 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
K013084,K013084
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
1654e7ab-b6fa-4019-ab43-c44747a6f039
Public Version Date
December 19, 2018
Public Version Number
4
DI Record Publish Date
August 17, 2015
Package DI Number
20721902363591
Quantity per Package
6
Contains DI Package
00721902363597
Package Discontinue Date
October 05, 2018
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |