Duns Number:480240820
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
011-424
Brand Name
OneTouch Ultra Blue
Version/Model Number
011-424
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
24bff368-ddee-464d-916f-1169a725b995
Public Version Date
July 26, 2019
Public Version Number
3
DI Record Publish Date
September 13, 2017
Package DI Number
20353885011567
Quantity per Package
300
Contains DI Package
00353885011563
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |