Duns Number:079226216
Device Description: CARTRIDGE, CHEM8+
Catalog Number
09P31-25
Brand Name
i-STAT
Version/Model Number
09P31-25
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)
-
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
JGS
Product Code Name
ELECTRODE, ION SPECIFIC, SODIUM
Public Device Record Key
32d46465-261c-4472-9d0a-b68e2069a5f6
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
00054749001910
Quantity per Package
25
Contains DI Package
10054749001917
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 |