Duns Number:783518983
Device Description: Blood glucose control solution for use with Easy Step blood glucose testing system
Catalog Number
1201
Brand Name
Easy Step Control Solution - NORMAL
Version/Model Number
T506-64
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090629,K090629,K090629
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
b73b1809-39f7-49d9-9fa8-edc98e6f18e6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 26, 2016
Package DI Number
20891237001205
Quantity per Package
2
Contains DI Package
10891237001208
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |