Duns Number:783518983
Device Description: Blood Glucose Testing Monitor to be used with Easy Talk or Easy Plus II test stripsTest: G Blood Glucose Testing Monitor to be used with Easy Talk or Easy Plus II test stripsTest: GlucoseSample: Whole BloodPrinciple of the test method: Amperometric, glucose oxidaseTest sites: Fingertip, forearmMeasurement time: 6 secondsCode required: No code deviceMeasurement Range: 20~600 mg/dL (1.1~33.3mmol/L ).Batteries: 2 x AAA 1.5 V Alkaline 24A LR03
Catalog Number
1478
Brand Name
Easy Talk Blood Glucose Monitoring System
Version/Model Number
6277
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
d79cbfaa-25b5-422d-8b17-c71a622453d1
Public Version Date
October 03, 2019
Public Version Number
4
DI Record Publish Date
May 01, 2016
Package DI Number
10891237001475
Quantity per Package
5
Contains DI Package
00891237001478
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Case
| 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 |