Duns Number:006261481
Device Description: FILETR CB353 BIOAC 20M AFFINITY
Catalog Number
-
Brand Name
Affinity®
Version/Model Number
CB353
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2017
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
K001138,K001138
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
4139f879-10bd-41b9-82c1-9893a5ea736f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 16, 2015
Package DI Number
20681490008536
Quantity per Package
6
Contains DI Package
00681490008532
Package Discontinue Date
November 30, 2017
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 |