Duns Number:783518983
Device Description: 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monit 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monitoring system
Catalog Number
1195
Brand Name
Easy Step Blood Glucose Test Strips 50ct
Version/Model Number
T5D2-00
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
K090629,K090629,K090629,K090629
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
54af7c3b-fb14-42de-8576-0267df64ca0a
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 03, 2016
Package DI Number
30891237001196
Quantity per Package
280
Contains DI Package
00891237001195
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 |