VIVI CAP 11502018

GUDID 10854073007056

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: 10854073007056
• NIH Device Record Key: 381ee9db-5dbb-4c10-acad-a4d8c38f5551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVI CAP
• Version Model Number: 11502018
• Catalog Number: 11502018
• 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: false
• Serial Number: true
• 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	00854073007059 [Primary]
GS1	10854073007056 [Package]; Contains: 00854073007059; Package: inner pack [6 Units]; In Commercial Distribution
GS1	20854073007053 [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: 2022-04-22
• Device Publish Date: 2022-04-14

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