Duns Number:480240820
Device Description: OneTouch Ping Blood Glucose Management System. Meter Remote
Catalog Number
023-049
Brand Name
OneTouch Ping
Version/Model Number
023-049
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)
-
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
0e4551fa-cfcf-4733-8226-b103c06eba4a
Public Version Date
July 26, 2019
Public Version Number
4
DI Record Publish Date
December 14, 2017
Package DI Number
20353885011673
Quantity per Package
15
Contains DI Package
00353885011679
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 |