Duns Number:043251054
Device Description: UniStrip1 Generic Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, U UniStrip1 Generic Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchased before October 2012.
Catalog Number
024850
Brand Name
UniStrip1 Generic Blood Glucose Test Strip
Version/Model Number
024850
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
6871fe86-34a6-44b9-b928-2319ffc4aabe
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
00389167348508
Quantity per Package
24
Contains DI Package
00389167248501
Package Discontinue Date
-
Package Status
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 |