Duns Number:051957769
Device Description: The ReliOn Premier Compact Blood Glucose Monitoring System is intended for the quantitativ The ReliOn Premier Compact Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.Carton contains: ReliOn Premier Compact Meter DI# 30681131240728, ReliOn Premier Test Strips 50ct DI# 00681131169776, Lancing Device, Lancets and Literature.
Catalog Number
-
Brand Name
ReliOn™ Premier Compact Blood Glucose Monitoring System
Version/Model Number
783110
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
-
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
79d3c837-6485-4855-a23c-e62d702fb5fa
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 31, 2018
Package DI Number
10681131240724
Quantity per Package
4
Contains DI Package
00681131240727
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| 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 |