AccessGUDID - DEVICE: DispenSecur (00860011977513)

GUDID

Device Identifier (DI) Information

Brand Name: DispenSecur
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Verinetics Inc

Primary DI Number: 00860011977513
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968420724 *Terms of Use

Device Description: DispenSecur is a device intended for medical purposes to provide alerts and controlled patient access to medication based on dosing schedules predetermined by a healthcare provider. The device may be used with either liquid or solid dosage forms of one medication type. The device is not intended to manage multiple medications.

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):	Yes
Over the Counter (OTC):	No
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?
61799	Personal pill dose dispenser, electric	An electrically-powered device designed to automatically dispense the correct dose of an individual patient’s medication pills at specified times. It is typically a computerized, programmable, tabletop unit loaded with the patient’s pills; the pills are not included. The device is intended to be operated by laypersons and healthcare providers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXQ	Reminder, Medication

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 -13 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -13 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 961d2946-7a42-4d91-b7ed-4b3158f5b870
Public Version Date: September 09, 2024
Public Version Number: 1
DI Record Publish Date: August 30, 2024