AccessGUDID - DEVICE: Dosentrx Ltd (07290018680001)

GUDID

Device Identifier (DI) Information

Brand Name: Dosentrx Ltd
Version or Model: ReX Companion
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ReX-C-2
Company Name: DOSENTRX LTD

Primary DI Number: 07290018680001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600071463 *Terms of Use

Device Description: ReX™ empowers you on your journey to better health. It is your personal companion that keeps you connected with your care team.

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):	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
NXB	Dispenser, Solid 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
Special Storage Condition, Specify: High value humidity 80% High value temperature 40C/104F
Special Storage Condition, Specify: Keep away from sunlight Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ded8c573-63ff-4892-917d-ed06c5b21557
Public Version Date: March 18, 2025
Public Version Number: 2
DI Record Publish Date: July 23, 2021