Duns Number:006261481
Device Description: FILTER CB851 AF100 WITH CARMEDA
Catalog Number
-
Brand Name
Affinity®
Version/Model Number
CB851
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 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
-
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
e5e83f07-4cc5-4fb3-a0d1-d636d3499e16
Public Version Date
September 22, 2022
Public Version Number
4
DI Record Publish Date
June 16, 2015
Package DI Number
20643169178032
Quantity per Package
4
Contains DI Package
00643169178038
Package Discontinue Date
October 21, 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 |