Duns Number:151810868
Device Description: H-E-B in Control TRUEtrack Blood Glucose Monitoring System
Catalog Number
A4031-81
Brand Name
TRUEtrack
Version/Model Number
TRUEtrack Blood Glucose Monitoring System
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 07, 2019
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
K032657,K032657
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
9c16e4c2-5fdd-4886-b9ff-85e5a291fd60
Public Version Date
November 01, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
10041220842435
Quantity per Package
12
Contains DI Package
00041220842438
Package Discontinue Date
October 07, 2019
Package Status
Not 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |