VIVI CAP 11602022

GUDID 10854073007087

A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen), 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

• Primary Device ID: 10854073007087
• NIH Device Record Key: c0167af3-29af-4340-b2f5-6cd01de7d62e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVI CAP
• Version Model Number: 11602022
• Catalog Number: 11602022
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854073007080 [Primary]
GS1	10854073007087 [Package]; Contains: 00854073007080; Package: Inner pack [5 Units]; In Commercial Distribution
GS1	20854073007084 [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: 2022-05-12
• Device Publish Date: 2022-05-04

On-Brand Devices [VIVI CAP]

• 10854073007056: A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an aut
• 10854073007049: A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an aut
• 10854073007087: A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an aut