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
-
Brand Name
GenUltimate
Version/Model Number
300-25
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
K103542,K103542,K103542,K103542
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
bbdf07e1-f766-4df0-8b0a-ffb0267848e6
Public Version Date
January 20, 2020
Public Version Number
1
DI Record Publish Date
January 10, 2020
Package DI Number
10850015460033
Quantity per Package
12
Contains DI Package
00850015460036
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-