Duns Number:783518983
Device Description: Blood Glucose Testing Monitor to be used with Easy Trak test strips
Catalog Number
1416
Brand Name
Easy Trak Blood Glucose Monitoring System
Version/Model Number
100030042
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
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
d7f31dbb-a3f4-4086-8720-b2188ec4c935
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 01, 2016
Package DI Number
10891237001413
Quantity per Package
50
Contains DI Package
00891237001416
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
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 |