Duns Number:006261481
Device Description: CARDIOTOMY EL400 4 LITER 120 MICRON
Catalog Number
-
Brand Name
NA
Version/Model Number
EL400
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K926250,K926250
Product Code
DTN
Product Code Name
RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
Public Device Record Key
e96ba8b9-eb74-4e1c-9f5c-56526dac97e5
Public Version Date
January 22, 2020
Public Version Number
5
DI Record Publish Date
June 16, 2016
Package DI Number
20673978523570
Quantity per Package
6
Contains DI Package
00673978523576
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 |