Duns Number:783518983
Device Description: 25ct bottle Blood Glucose Testing Strips for use with Easy Plus II or Easy Talk monitoring 25ct bottle Blood Glucose Testing Strips for use with Easy Plus II or Easy Talk monitoring systems
Catalog Number
1645
Brand Name
Easy Plus II Blood Glucose Testing Strips 25ct
Version/Model Number
8818
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
-
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
7e7ccefb-b91e-4c1f-bd50-56b337cf5666
Public Version Date
June 14, 2018
Public Version Number
3
DI Record Publish Date
May 03, 2016
Package DI Number
10891237001642
Quantity per Package
2
Contains DI Package
00891237001645
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |