AccessGUDID - DEVICE: cue-Rx (00860000925907)

GUDID

Device Identifier (DI) Information

Brand Name: cue-Rx
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ONE WORLD DESIGN AND MANUFACTURING GROUP LTD

Primary DI Number: 00860000925907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829340343 *Terms of Use

Device Description: Medication management system

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8287f216-058c-476a-9239-c221954278c4
Public Version Date: October 29, 2021
Public Version Number: 2
DI Record Publish Date: March 20, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 908 769 1234
Email: matt@oneworlddmg.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES