Duns Number:783518983
Device Description: Easy Trak II Control Solution High for use with Easy Trak II strips in the Easy Trak II me Easy Trak II Control Solution High for use with Easy Trak II strips in the Easy Trak II meter. For use only within 90 days of opening.Do not use after expiration date.
Catalog Number
-
Brand Name
Easy Trak II Control Solution High
Version/Model Number
1
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
K052208,K052208
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
cc7affec-b084-432a-b29d-b7a5201cc34b
Public Version Date
January 20, 2020
Public Version Number
1
DI Record Publish Date
January 10, 2020
Package DI Number
10850632007383
Quantity per Package
750
Contains DI Package
00850632007386
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| 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 |