Duns Number:783518983
Device Description: Blood glucose control solution for use with Trak blood glucose testing system
Catalog Number
1461
Brand Name
Easy Trak Control Solution - LOW
Version/Model Number
100040005
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
K090389,K090389,K090389,K090389
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
4ebc93dd-5475-40f1-9ab5-2af02f8037e5
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 01, 2016
Package DI Number
10891237001468
Quantity per Package
100
Contains DI Package
00891237001461
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| 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 |