Duns Number:079226216
Device Description: Kaolin ACT CARTRIDGE
Catalog Number
03P87-25
Brand Name
i-STAT
Version/Model Number
03P87-25
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)
Yes
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
-
Product Code
JBP
Product Code Name
ACTIVATED WHOLE BLOOD CLOTTING TIME
Public Device Record Key
5e6ca8e1-2af0-4474-9f69-07d0e41c66f5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2016
Package DI Number
00054749000159
Quantity per Package
25
Contains DI Package
10054749000156
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |
| 3 | A medical device with high risk that requires premarket approval | 14 |