VIVI CAP SMART 12002025

GUDID 10854073007100

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. Additionally, it has an incorporated timer mechanism to help people know how long it has been since they last took their medication and an optional connected cell phone application used as a log book to store the time information and amount of medication that has been injected.

Tempramed

Autoinjector insulation case

• Primary Device ID: 10854073007100
• NIH Device Record Key: 583738da-0db0-41f0-b3f3-6069d6068b52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVI CAP SMART
• Version Model Number: 12002025
• Catalog Number: 12002025
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854073007103 [Primary]
GS1	10854073007100 [Package]; Contains: 00854073007103; Package: Inner pack [5 Units]; In Commercial Distribution
GS1	20854073007107 [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: 2025-12-17
• Device Publish Date: 2025-12-09

Devices Manufactured by Tempramed

• 10854073007100 - VIVI CAP SMART: 2025-12-17A 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. Additionally, it has an incorporated timer mechanism to help people know how long it has been since they last took their medication and an optional connected cell phone application used as a log book to store the time information and amount of medication that has been injected.
• 10854073007100 - VIVI CAP SMART: 2025-12-17 A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen),
• 00854073007127 - VIVI MED: 2025-12-17 A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen, Ep
• 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),