Duns Number:051957769
Device Description: ReliOn Premier Blood Glucose Test Strips are for use with the ReliOn Premier family of blo ReliOn Premier Blood Glucose Test Strips are for use with the ReliOn Premier family of blood glucose meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. Alternative site testing (AST) should only be used during steady-state blood glucose conditions. The ReliOn Premier family of blood glucose monitoring systems are intended for self-testing outside the body (in vitro) by people with diabetes as an aid to monitor the effectiveness of diabetes control. They are not intended for use on neonates, and they are not for the diagnosis or screening of diabetes.
Catalog Number
-
Brand Name
ReliOn™ Premier Blood Glucose Test Strips
Version/Model Number
780025
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
K121133,K121133,K121133,K121133
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
a0eceb34-59d9-4c93-a5d4-77050573ca80
Public Version Date
August 29, 2019
Public Version Number
1
DI Record Publish Date
August 21, 2019
Package DI Number
20681131285746
Quantity per Package
45
Contains DI Package
10681131285749
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |