VIVI EPI 21002022

GUDID 10854073007094

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.

Tempramed

Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case 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

Customer Support Contacts

• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com
• Phone: +1 (800) 871-9923
• Email: info@tempramed.com

Operating and Storage Conditions

• 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 Identifiers

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

FDA Product Code

• OJL: Insulin Vial Protector/Holder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-09
• Device Publish Date: 2022-09-01

Devices Manufactured by Tempramed

• 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),