Duns Number:051957769
Device Description: The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the quantitative The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
Catalog Number
-
Brand Name
ReliOn™ Premier Voice Basic Meter
Version/Model Number
780001
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
K121133,K121133
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
0acbfeb8-9287-4f76-9af6-a27faea6206e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 14, 2017
Package DI Number
10681131169858
Quantity per Package
4
Contains DI Package
00681131169851
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Shipper
| 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 |