Duns Number:688195374
Device Description: Blood Glucose Monitoring System
Catalog Number
-
Brand Name
Element™Plus Test Strips
Version/Model Number
IGM-0021B
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
K103021,K103021
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
ac0988cb-de2d-48c7-8f92-16a3aff8848a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 21, 2017
Package DI Number
08809115908964
Quantity per Package
2
Contains DI Package
08809115908957
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |