Duns Number:480240820
Device Description: OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
Catalog Number
021-100
Brand Name
OneTouch Ultra2
Version/Model Number
021-100
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
-
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
K053529,K053529
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
245f3a44-cc25-49bf-90ac-278bde9d77e8
Public Version Date
July 26, 2019
Public Version Number
4
DI Record Publish Date
September 13, 2017
Package DI Number
20353885008857
Quantity per Package
10
Contains DI Package
00353885008853
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 |