Duns Number:070617139
Device Description: StatSensor Creatinine Meter with Battery and Quick Reference Guide
Catalog Number
44052
Brand Name
StatSensor
Version/Model Number
1.0
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070068,K070068
Product Code
CGL
Product Code Name
ELECTRODE, ION BASED, ENZYMATIC, CREATININE
Public Device Record Key
48c6926e-4ba3-458a-be73-5c7202864577
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10385480440520
Quantity per Package
1
Contains DI Package
00385480440523
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 165 |
2 | A medical device with a moderate to high risk that requires special controls. | 210 |