VIVI EPI 21002022

GUDID 10854073007094

Autoinjector insulation case

Primary Device ID	10854073007094
NIH Device Record Key	c9deeaaa-4c30-404c-8cef-57018c248373
Commercial Distribution Status	In Commercial Distribution
Brand Name	VIVI EPI
Version Model Number	21002022
Catalog Number	21002022
Company DUNS	055540325
Company Name	Tempramed
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00854073007097 [Primary]
GS1	10854073007094 [Package] Contains: 00854073007097 Package: Inner Pack [4 Units] In Commercial Distribution
GS1	20854073007091 [Package] Package: Case [10 Units] In Commercial Distribution

OJL	Insulin Vial Protector/Holder

Steralize Prior To Use	false
Device Is Sterile	false

10854073007094 - VIVI EPI	2022-09-09A 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.
10854073007094 - VIVI EPI	2022-09-09 A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen, Ep
10854073007087 - VIVI CAP	2022-05-12 A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen),
10854073007049 - VIVI CAP	2022-04-22 A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen),
10854073007056 - VIVI CAP	2022-04-22 A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen),

Mark Image Registration \| Serial	Company Trademark Application Date
VIVI EPI 87111229 not registered Live/Pending	Nagar, Ron 2016-07-21