AccessGUDID - DEVICE: VIVI EPI (00854073007097)

GUDID

Device Identifier (DI) Information

Brand Name: VIVI EPI
Version or Model: 21002022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21002022
Company Name: Tempramed

Primary DI Number: 00854073007097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055540325 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63067	Autoinjector insulation case	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJL	Insulin Vial Protector/Holder
IQG	Adaptor, Holder, Syringe

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c9deeaaa-4c30-404c-8cef-57018c248373
Public Version Date: September 09, 2022
Public Version Number: 1
DI Record Publish Date: September 01, 2022