Duns Number:055540325
Device Description: A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen, EpiPen or similar) or one or more vials, in order to maintain its contents within a specific temperature range while being carried by the patient. It is in the form of a small cylinder, which may also function as a cap for the autoinjector, and is made of thermal-insulating material and a phase change material (PCM). It includes electronics that provides indication of medication temperature.
Catalog Number
21002022
Brand Name
VIVI EPI
Version/Model Number
21002022
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
-
Product Code
IQG
Product Code Name
Adaptor, Holder, Syringe
Public Device Record Key
c9deeaaa-4c30-404c-8cef-57018c248373
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
10854073007094
Quantity per Package
4
Contains DI Package
00854073007097
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack