FDA.reportPublic FDA data

VIVI CAP SMART Cover

Primary DI
00854073007110
Brand
VIVI CAP SMART Cover
Company
Tempramed
Model
12102025
Catalog number
12102025
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
Published
2026-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXQReminder, Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXQReminder, MedicationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854073007117PackageGS18In Commercial Distribution
20854073007114PackageGS110In Commercial Distribution
00854073007110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085407300711710854073007117
2085407300711420854073007114
00854073007110008540730071108540730071100854073007110

GMDN Terms#

Term, Definition table
TermDefinition
Insulin autoinjector timerA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 871-9923info@tempramed.com

Regulatory Flags#

DUNS number
055540325
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854073007103VIVI CAP SMART12002025120020252025-12-09
10854073007100VIVI CAP SMART12002025120020252025-12-09
00854073007127VIVI MED31002025310020252025-12-09
00854073007097VIVI EPI21002022210020222022-09-01
10854073007094VIVI EPI21002022210020222022-09-01
00854073007080VIVI CAP11602022116020222022-05-04
10854073007087VIVI CAP11602022116020222022-05-04
00854073007042VIVI CAP11402018114020182022-04-14
00854073007059VIVI CAP11502018115020182022-04-14
10854073007049VIVI CAP11402018114020182022-04-14
10854073007056VIVI CAP11502018115020182022-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008267771Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
00860008267788Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
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B553202212OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-04-21
B553202294OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2026-03-30
B553202295OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2026-03-30
B553202311OTC0WelldocWELLDOC, INC.NXQ2026-03-09
B553202312OTC0WelldocWELLDOC, INC.NXQ2026-03-09
B553202313OTC0WelldocWELLDOC, INC.NXQ2026-03-09
07350149360033PD Care SystemPainDrainer ABNXQ2026-03-04
00086001518102iTonic MediTrust Automated Medication Management SystemGERI-SAFE, LTD.NXQ2026-02-05
00854073007103VIVI CAP SMARTTempramedNXQ2025-12-09
07350149360026PD Care SystemPainDrainer ABNXQ2025-11-13
B553202301OTC0WelldocWELLDOC, INC.NXQ2025-07-21
B553202302OTC0WelldocWELLDOC, INC.NXQ2025-07-21
B553202303OTC0WelldocWELLDOC, INC.NXQ2025-07-21
B553202201OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2025-06-03
B553202202OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2025-05-28
00300021451554Lilly TogetherELI LILLY AND COMPANYNXQ2025-04-17
00300021458553Lilly TogetherELI LILLY AND COMPANYNXQ2025-04-17
B553202161OTC0MDLIVE Health CoachingWELLDOC, INC.NXQ2025-04-11
B553202162OTC0MDLIVE Health CoachingWELLDOC, INC.NXQ2025-04-11
B553202194OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2025-04-11
B553202195OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2025-04-11
00304692416447DIGITIVA Mobile ApplicationAstellas Pharma Us, Inc.NXQ2025-01-10
05419980275011Neuroventis PlatformNeuroventisNXQ2025-01-01
00304692416089DIGITIVA Mobile ApplicationAstellas Pharma Us, Inc.NXQ2024-12-12
00300021285555Lilly TogetherELI LILLY AND COMPANYNXQ2024-11-26
00300021286552Lilly TogetherELI LILLY AND COMPANYNXQ2024-11-26
00860011977513DispenSecurVerinetics IncNXQ2024-08-30