Duns Number:079226216
Device Description: Cartridge, CG4+
Catalog Number
-
Brand Name
i-STAT
Version/Model Number
03P85-51
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
K200492,K200492
Product Code
OWD
Product Code Name
Somatic gene mutation detection system
Public Device Record Key
d46180ba-046d-448b-9783-a311af190b56
Public Version Date
October 13, 2022
Public Version Number
2
DI Record Publish Date
October 05, 2020
Package DI Number
00054749005505
Quantity per Package
25
Contains DI Package
10054749005502
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |