Duns Number:006261481
Device Description: RESERVOIR EL402 4L 20MICR CARDIOTOMY 6CA
Catalog Number
-
Brand Name
NA
Version/Model Number
EL402
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)
-
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
2be5fe46-4489-4bd5-b857-9bda744cc4ac
Public Version Date
January 22, 2020
Public Version Number
4
DI Record Publish Date
June 24, 2016
Package DI Number
20673978523587
Quantity per Package
6
Contains DI Package
00673978523583
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CT
| 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 |