FDA.reportPublic FDA data

VIVI CAP SMART

Primary DI
00854073007103
Brand
VIVI CAP SMART
Company
Tempramed
Model
12002025
Catalog number
12002025
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.
Published
2025-12-09
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
IQGAdaptor, Holder, Syringe
NXQReminder, Medication
OJLInsulin Vial Protector/Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQGAdaptor, Holder, SyringePhysical Medicine1
NXQReminder, MedicationPhysical Medicine1
OJLInsulin Vial Protector/HolderPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854073007100PackageGS15In Commercial Distribution
20854073007107PackageGS110In Commercial Distribution
00854073007103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085407300710010854073007100
2085407300710720854073007107
00854073007103008540730071038540730071030854073007103

Storage And Handling#

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

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
00854073007110VIVI CAP SMART Cover12102025121020252026-03-01
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
00199284270657PowerFlow SyrinGun 20 mLORTHOSPINE ADVANCE HEALTH, INC., A CALIFORNIA PROFESSIONAL MEDICAL CORPORATIONIQG2026-10-20
B5530801001OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2026-10-14
B5530802001OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2026-10-14
B5531401001OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-07-17
B5531402001OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-07-17
06974405095074CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095173CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095180CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097290CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097306CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097313CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097320CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097559CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
00860008267771Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
00860008267788Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
B553202211OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-04-21
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
00854073007110VIVI CAP SMART CoverTempramedNXQ2026-03-01
00086001518102iTonic MediTrust Automated Medication Management SystemGERI-SAFE, LTD.NXQ2026-02-05
10854073007100VIVI CAP SMARTTempramedOJL2025-12-09
00854073007127VIVI MEDTempramedIQG2025-12-09
00854073007127VIVI MEDTempramedOJL2025-12-09
07350149360026PD Care SystemPainDrainer ABNXQ2025-11-13
00187207000467SealSafeAndwin ScientificIQG2025-08-14