VIVI CAP

Primary DI
00854073007059
Brand
VIVI CAP
Company
Tempramed
Model
11502018
Catalog number
11502018
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.
Published
2022-04-14
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
OJLInsulin Vial Protector/Holder

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854073007056PackageGS16In Commercial Distribution
20854073007053PackageGS110In Commercial Distribution
00854073007059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085407300705610854073007056
2085407300705320854073007053
00854073007059008540730070598540730070590854073007059

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector insulation caseA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
055540325
Device count
1
Premarket exempt
true
Serial number
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
00854073007127VIVI MED31002025310020252025-12-09
00854073007097VIVI EPI21002022210020222022-09-01
10854073007094VIVI EPI21002022210020222022-09-01
00854073007080VIVI CAP11602022116020222022-05-04
10854073007087VIVI CAP11602022116020222022-05-04
00854073007042VIVI CAP11402018114020182022-04-14
10854073007049VIVI CAP11402018114020182022-04-14
10854073007056VIVI CAP11502018115020182022-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854073007103VIVI CAP SMARTTempramedOJL2025-12-09
10854073007100VIVI CAP SMARTTempramedOJL2025-12-09
00854073007127VIVI MEDTempramedOJL2025-12-09
00854073007097VIVI EPITempramedOJL2022-09-01
10854073007094VIVI EPITempramedOJL2022-09-01
00854073007080VIVI CAPTempramedOJL2022-05-04
10854073007087VIVI CAPTempramedOJL2022-05-04
00854073007042VIVI CAPTempramedOJL2022-04-14
10854073007049VIVI CAPTempramedOJL2022-04-14
10854073007056VIVI CAPTempramedOJL2022-04-14