Duns Number:690543319
Device Description: SP PUMP HEAD ADAPTER
Catalog Number
XX*SP03
Brand Name
CAPIOX® SP PUMP
Version/Model Number
XX*SP03
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KFM
Product Code Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Public Device Record Key
9c725f07-6673-4d45-bf8a-1dc94eadf7e3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 17, 2015
Package DI Number
54987350734438
Quantity per Package
10
Contains DI Package
04987350734433
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |