VIVI CAP SMART Cover

Basic Information

• Brand Name: VIVI CAP SMART Cover
• Primary DI: 00854073007110
• Version / Model: 12102025
• Catalog Number: 12102025
• Company Name: Tempramed
• Labeler DUNS: 055540325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-01
• Public Version: 1
• Public Version Date: 2026-03-09
• Public Version Status: New
• Public Device Record Key: 950ea8cf-d7eb-4393-a870-2c550f1192c0

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXQ	Reminder, Medication	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43081	Medication reminder application software	An individual software program or group of programs, routines and/or algorithms, that are used together with a mobile phone (cell phone) or other communication device to function as a medication reminder. It is intended for medical purposes to provide alerts to patients and healthcare providers for predetermined medication dosing schedules. It may also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills.	No	Active
60352	Insulin autoinjector timer	A battery-powered device intended to be used with an insulin autoinjector (insulin pen) to provide the patient with an indication of time elapsed since last insulin injection to help manage self-administration of insulin injections. It is in the form of a pen cap with an integrated timer that typically starts timing when placed on the pen and resets soon after being removed. It is intended to replace the pen’s original protective cap and is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854073007110	GS1
Package	10854073007117	GS1	inner pack	8	In Commercial Distribution
Package	20854073007114	GS1	Case	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 30 Degrees Celsius