Duns Number:099981040
Device Description: 20 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increme 20 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments
Catalog Number
8560-9600-03
Brand Name
V-Go Disposable Insulin Delivery
Version/Model Number
V-Go 20
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
K103825,K103825,K103825
Product Code
LZG
Product Code Name
Pump, Infusion, Insulin
Public Device Record Key
6bd717e8-5467-4100-a170-47091193f1bd
Public Version Date
June 30, 2022
Public Version Number
7
DI Record Publish Date
May 24, 2016
Package DI Number
10385609600033
Quantity per Package
10
Contains DI Package
00385609600036
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton