FDA UDI
In Commercial Distribution
🇺🇸 United States
cue-Rx
DI: 00860000925907
·
Model: 1
·
ONE WORLD DESIGN AND MANUFACTURING GROUP LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- cue-Rx
- Primary DI
- 00860000925907
- Version / Model
- 1
- Company Name
- ONE WORLD DESIGN AND MANUFACTURING GROUP LTD
- Labeler DUNS
- 829340343
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-20
- Public Version
- 2
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 8287f216-058c-476a-9239-c221954278c4
Device Description
Medication management system
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NXB | Dispenser, Solid Medication | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860000925907 | GS1 |
Customer Contacts
- Phone
- 908 769 1234
- [email protected]