Duns Number:134139174
Device Description: CO - SET MOD ROOM TEMPERATURE STERILE
Catalog Number
MK2431
Brand Name
CO-SET+
Version/Model Number
MK2431
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
K811399,K811399
Product Code
KRB
Product Code Name
PROBE, THERMODILUTION
Public Device Record Key
d24bf144-a0af-47d5-9e94-1afcaeda5364
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 03, 2016
Package DI Number
57460691955443
Quantity per Package
10
Contains DI Package
07460691955448
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |