Duns Number:006261481
Device Description: PUMP CBAP40 AFF CP CENTRIF CC US/CAN 4PK
Catalog Number
-
Brand Name
Affinity™ CP
Version/Model Number
CBAP40
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
K132712,K132712
Product Code
KFM
Product Code Name
Pump, blood, cardiopulmonary bypass, non-roller type
Public Device Record Key
fd2396ea-4ac1-46e6-89a3-f5bc45053d91
Public Version Date
May 19, 2020
Public Version Number
4
DI Record Publish Date
January 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |