VIVI CAP SMART

Basic Information

• Brand Name: VIVI CAP SMART
• Primary DI: 00854073007103
• Version / Model: 12002025
• Catalog Number: 12002025
• Company Name: Tempramed
• Labeler DUNS: 055540325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-09
• Public Version: 1
• Public Version Date: 2025-12-17
• Public Version Status: New
• Public Device Record Key: 583738da-0db0-41f0-b3f3-6069d6068b52

Device Description

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.

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
OJL	Insulin Vial Protector/Holder	Physical Medicine	890.5050	1
IQG	Adaptor, Holder, Syringe	Physical Medicine	890.5050	1
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
63067	Autoinjector insulation case	A portable, electronic, thermal-insulating device designed to contain an autoinjector (e.g., insulin pen), or other portable medication vial, 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 materials, typically a phase change material (PCM). Its electronics enable functions related to indication of medication temperature, administration scheduling/events, and/or wireless connectivity. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10854073007100	GS1	Inner pack	5	In Commercial Distribution
Primary	00854073007103	GS1
Package	20854073007107	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