VIVI CAP SMART Cover 12102025

GUDID 00854073007110

Aa complementary addition to the VIVI Cap, which can be used only with the VIVI Cap device. 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

Insulin autoinjector timer

• Primary Device ID: 00854073007110
• NIH Device Record Key: 950ea8cf-d7eb-4393-a870-2c550f1192c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVI CAP SMART Cover
• Version Model Number: 12102025
• Catalog Number: 12102025
• 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	00854073007110 [Primary]
GS1	10854073007117 [Package]; Package: inner pack [8 Units]; In Commercial Distribution
GS1	20854073007114 [Package]; Contains: 10854073007117; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• NXQ: Reminder, Medication

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: 2026-03-09
• Device Publish Date: 2026-03-01

Devices Manufactured by Tempramed

• 00854073007110 - VIVI CAP SMART Cover: 2026-03-09Aa complementary addition to the VIVI Cap, which can be used only with the VIVI Cap device. 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
• 00854073007110 - VIVI CAP SMART Cover: 2026-03-09 Aa complementary addition to the VIVI Cap, which can be used only with the VIVI Cap device. It has an incorporated timer mechani
• 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),