Duns Number:829145387
Device Description: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® Ult Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters
Catalog Number
100-10
Brand Name
GenUltimate!
Version/Model Number
Catalog Number: 100-10
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
2667a4ea-2ba7-4cbb-8322-266b3e065492
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 24, 2017
Package DI Number
10867396000321
Quantity per Package
432
Contains DI Package
00867396000324
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case