VIVI EPI

Basic Information

• Brand Name: VIVI EPI
• Primary DI: 00854073007097
• Version / Model: 21002022
• Catalog Number: 21002022
• Company Name: Tempramed
• Labeler DUNS: 055540325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-01
• Public Version: 1
• Public Version Date: 2022-09-09
• Public Version Status: New
• Public Device Record Key: c9deeaaa-4c30-404c-8cef-57018c248373

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJL	Insulin Vial Protector/Holder	Physical Medicine	890.5050	1
IQG	Adaptor, Holder, Syringe	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63067	Autoinjector insulation case	A portable, electronic, thermal-insulating device designed to contain an autoinjector (e.g., insulin pen), or other portable medication vial, 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 materials, typically a phase change material (PCM). Its electronics enable functions related to indication of medication temperature, administration scheduling/events, and/or wireless connectivity. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10854073007094	GS1	Inner Pack	4	In Commercial Distribution
Primary	00854073007097	GS1
Package	20854073007091	GS1	Case	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius