Duns Number:006261481
Device Description: FILTER CB4014 AFF PED ART CC ST CEM 4PK
Catalog Number
-
Brand Name
Affinity®
Version/Model Number
CB4014
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
K071253,K071253
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
6d8a2d4d-bab1-4189-8499-203d4c231b79
Public Version Date
December 13, 2018
Public Version Number
4
DI Record Publish Date
June 17, 2015
Package DI Number
20613994404897
Quantity per Package
4
Contains DI Package
00613994404893
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 |