FDA UDI
In Commercial Distribution
🇺🇸 United States
Relivion MG App
DI: 07290018393147
·
Model: RLV-PMI-102
·
NEUROLIEF LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Relivion MG App
- Primary DI
- 07290018393147
- Version / Model
- RLV-PMI-102
- Company Name
- NEUROLIEF LTD
- Labeler DUNS
- 600484465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-19
- Public Version
- 2
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- b4e04d98-ae2d-4dd3-aa0d-2965c5e4de53
Device Description
An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Neurology | 882.5891 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60065 | Configurable electronic form web-based application software | An application software program designed as an Internet-based information system intended to replace paper forms by electronically collecting and recording all types of patient clinical information, investigation results, and treatment data. It is a generic system which can be used in healthcare by configuration of workflows, metadata, and data lifecycles; and by integration into electronic medical record (EMR) systems using standard protocols. The electronic forms are intended to provide predefined workflow, input, search, and display functionalities, typically to manage a particular treatment or condition [e.g., hyposensitization (allergy desensitization), cleft lip]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018393147 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212106 | 000 |