Duns Number:006261481
Device Description: CARDIOPLEGIA 61399405331 MYO XP 4:1B 4PK
Catalog Number
-
Brand Name
MyOtherm XP®
Version/Model Number
61399405331
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
K971105,K971105
Product Code
DTN
Product Code Name
RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
Public Device Record Key
83ef0eb6-9d81-4f74-ac87-90ddd6f880eb
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2014
Package DI Number
20613994947745
Quantity per Package
4
Contains DI Package
00613994947741
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 |