Duns Number:153409313
Device Description: OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
Catalog Number
024-273
Brand Name
OneTouch Ultra Blue Test Strips
Version/Model Number
024-273
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
c8e30e04-8c2a-4ddc-9b99-bcfb6757bcb0
Public Version Date
August 05, 2022
Public Version Number
1
DI Record Publish Date
July 28, 2022
Package DI Number
20353885012656
Quantity per Package
24
Contains DI Package
00353885012652
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper