Duns Number:006261481
Device Description: CONTROL 550-12 CLOTTRAC HTC 15BX
Catalog Number
-
Brand Name
CLOTtrac™
Version/Model Number
550-12
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
K062348,K062348
Product Code
JBP
Product Code Name
ACTIVATED WHOLE BLOOD CLOTTING TIME
Public Device Record Key
ae749d97-064f-4afb-bda0-5f72b8064705
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 06, 2018
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 | 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 |