Duns Number:968998641
Device Description: OneTouch Ping Blood Glucose Management System For self-testing. For Quantitative measureme OneTouch Ping Blood Glucose Management System For self-testing. For Quantitative measurement of glucose in whole blood. For in vitro diagnostic use only
Catalog Number
-
Brand Name
OneTouch Ping
Version/Model Number
023-049
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082590,K082590
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
7ffcb6a3-cab2-4989-b090-379db924078e
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
September 13, 2017
Package DI Number
20353885010201
Quantity per Package
15
Contains DI Package
00353885010207
Package Discontinue Date
July 21, 2020
Package Status
Not 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. | 12 |
| 3 | A medical device with high risk that requires premarket approval | 45 |