Duns Number:968998641
Device Description: OTP PUMP W/O KIT, LGN, US
Catalog Number
10543500
Brand Name
OneTouch Ping
Version/Model Number
10543500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
LZG
Product Code Name
PUMP, INFUSION, INSULIN
Public Device Record Key
88b942be-49cd-4c34-956f-61f77279dc9a
Public Version Date
August 04, 2021
Public Version Number
5
DI Record Publish Date
August 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |