Duns Number:006261481
Device Description: ARTERIAL FILTER BB4014PEDS BB STERILE
Catalog Number
-
Brand Name
Affinity Pixie™
Version/Model Number
BB4014
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
K100646,K100646
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
17188d2c-160c-437c-b5f3-0ef5d5858449
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 24, 2017
Package DI Number
20643169878123
Quantity per Package
4
Contains DI Package
00643169878129
Package Discontinue Date
-
Package Status
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 |