Duns Number:043251054
Device Description: Equate Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, UltraMini & Equate Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
Catalog Number
038600
Brand Name
Equate Blood Glucose Test Strips
Version/Model Number
038600
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
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
215d2f11-b06a-4575-bb52-706f97cd61a8
Public Version Date
February 06, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
00681131304863
Quantity per Package
24
Contains DI Package
00681131104869
Package Discontinue Date
February 05, 2020
Package Status
Not in Commercial Distribution
Package Type
Corrugated Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |