VIVI CAP 11502018
GUDID 10854073007056
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.
Tempramed
Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case Autoinjector insulation case| Primary Device ID | 10854073007056 |
| NIH Device Record Key | 381ee9db-5dbb-4c10-acad-a4d8c38f5551 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VIVI CAP |
| Version Model Number | 11502018 |
| Catalog Number | 11502018 |
| Company DUNS | 055540325 |
| Company Name | Tempramed |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com | |
| Phone | +1 (800) 871-9923 |
| info@tempramed.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854073007059 [Primary] |
| GS1 | 10854073007056 [Package] Contains: 00854073007059 Package: inner pack [6 Units] In Commercial Distribution |
| GS1 | 20854073007053 [Package] Package: case [10 Units] In Commercial Distribution |
FDA Product Code
| OJL | Insulin Vial Protector/Holder |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-22 |
| Device Publish Date | 2022-04-14 |
On-Brand Devices [VIVI CAP]
| 10854073007056 | A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an aut |
| 10854073007049 | A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an aut |
| 10854073007087 | A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an aut |
Trademark Results [VIVI CAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIVI CAP 87052076 5267284 Live/Registered |
Nagar, Ron 2016-05-27 |
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