Duns Number:006261481
Device Description: PUMP AP40 AFFINITY CP CENTRIFUGAL NC
Catalog Number
-
Brand Name
Affinity™ CP
Version/Model Number
AP40
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
2a0ee02e-098e-466c-9e53-d4858f50c45f
Public Version Date
May 19, 2020
Public Version Number
4
DI Record Publish Date
October 30, 2016
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 |