Duns Number:006261481
Device Description: OXYGENATOR 95215 TRILLIUM AFF 511T 4PK
Catalog Number
-
Brand Name
TRILLIUM® Affinity NT®
Version/Model Number
95215
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 14, 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
K973760,K973760
Product Code
DTZ
Product Code Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Public Device Record Key
9627b7bd-47ee-4ce5-a8a9-e758bcbc1243
Public Version Date
October 19, 2022
Public Version Number
6
DI Record Publish Date
June 16, 2015
Package DI Number
20613994865971
Quantity per Package
4
Contains DI Package
00613994865977
Package Discontinue Date
November 14, 2019
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 |