FDA.reportPublic FDA data

VIVI MED

Primary DI
00854073007127
Brand
VIVI MED
Company
Tempramed
Model
31002025
Catalog number
31002025
Device description
A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen, EpiPen or similar) or one or more vials, 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.
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
OJLInsulin Vial Protector/Holder

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854073007124PackageGS14In Commercial Distribution
20854073007121PackageGS16In Commercial Distribution
00854073007127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085407300712410854073007124
2085407300712120854073007121
00854073007127008540730071278540730071270854073007127

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
00854073007110VIVI CAP SMART Cover12102025121020252026-03-01
00854073007103VIVI CAP SMART12002025120020252025-12-09
10854073007100VIVI CAP SMART12002025120020252025-12-09
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
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
00854073007103VIVI CAP SMARTTempramedIQG2025-12-09
00854073007103VIVI CAP SMARTTempramedOJL2025-12-09
10854073007100VIVI CAP SMARTTempramedOJL2025-12-09
00187207000467SealSafeAndwin ScientificIQG2025-08-14
00187207000474SealSafeAndwin ScientificIQG2025-08-14
00187207000481SealSafeAndwin ScientificIQG2025-08-14
00187207000498SealSafeAndwin ScientificIQG2025-08-14
00187207000504SealSafeAndwin ScientificIQG2025-08-14
00187207000511SealSafeAndwin ScientificIQG2025-08-14
00817771028849Celling Cardio Application KitCelling BiosciencesIQG2025-04-11
00817771029600Celling Application KitCelling BiosciencesIQG2025-04-11
00860425001620Certa Dose PALS Syringe Holder CD Acquisitions, LLCIQG2025-03-03
00614950030163ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031191ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031320ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00850003042305Extremity CareExtremity CareIQG2023-03-30
00854073007097VIVI EPITempramedIQG2022-09-01
00854073007097VIVI EPITempramedOJL2022-09-01
10854073007094VIVI EPITempramedOJL2022-09-01
00854073007080VIVI CAPTempramedOJL2022-05-04
10854073007087VIVI CAPTempramedOJL2022-05-04