Duns Number:079226216
Device Description: I-STAT ALINITY INSTRUMENT (MODEL 500)
Catalog Number
-
Brand Name
i-STAT
Version/Model Number
02R60-81
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
-
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
83613bc9-4a65-4b5b-bebc-ea0ea6f8e6d7
Public Version Date
October 20, 2021
Public Version Number
1
DI Record Publish Date
October 12, 2021
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 | 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 |