Duns Number:079226216
Device Description: i-STAT ACT, CONTROL LEVEL 1
Catalog Number
06P17-15
Brand Name
i-STAT
Version/Model Number
06P17-15
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
GGN
Product Code Name
PLASMA, COAGULATION CONTROL
Public Device Record Key
b7c88466-6579-4f39-8011-ca1a2c0a3402
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2016
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 |