Duns Number:006261481
Device Description: OXYGENATOR CB511 AFFINITY BIOACT 4PK
Catalog Number
-
Brand Name
Affinity NT™
Version/Model Number
CB511
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
K162016,K162016
Product Code
DTZ
Product Code Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Public Device Record Key
3e0869a0-9858-4500-8461-daeb040f7be3
Public Version Date
September 22, 2022
Public Version Number
5
DI Record Publish Date
January 03, 2017
Package DI Number
20643169767854
Quantity per Package
4
Contains DI Package
00643169767843
Package Discontinue Date
-
Package Status
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 |