Duns Number:966390890
Device Description: Optium EZ Blood Glucose Monitoring System
Catalog Number
71065
Brand Name
OptiumEZ
Version/Model Number
71065
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
K081975,K081975
Product Code
JJX
Product Code Name
SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
Public Device Record Key
343b1517-2bad-468a-ab0e-014b49dc68e8
Public Version Date
February 26, 2019
Public Version Number
4
DI Record Publish Date
August 12, 2016
Package DI Number
30093815710654
Quantity per Package
30
Contains DI Package
00093815710653
Package Discontinue Date
-
Package Status
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 2 |