Duns Number:783518983
Device Description: 25ct bottle Easy Trak blood glucose test strips for use with Easy Trak blood glucose monit 25ct bottle Easy Trak blood glucose test strips for use with Easy Trak blood glucose monitoring system
Catalog Number
1423
Brand Name
Easy Trak Blood Glucose Test Strips 25ct
Version/Model Number
200020049
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090389,K090389,K090389,K090389,K090389
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
d8255b8a-62ba-4a7c-93f3-72ff34414082
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 03, 2016
Package DI Number
10891237001420
Quantity per Package
2
Contains DI Package
00891237001423
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |