Duns Number:070156955
Device Description: System Transporter
Catalog Number
CM2TR00
Brand Name
CentriMag™
Version/Model Number
CM2TR00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KRI
Product Code Name
ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS
Public Device Record Key
bde5ed57-ea2c-4f7c-9be3-fa51ea240e12
Public Version Date
September 07, 2022
Public Version Number
1
DI Record Publish Date
August 30, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 156 |