FDA UDI
Not in Commercial Distribution
🇺🇸 United States
REMI
DI: 08600053881650
·
Model: R001
·
Epitel, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- REMI
- Primary DI
- 08600053881650
- Version / Model
- R001
- Company Name
- Epitel, Inc.
- Labeler DUNS
- 808401157
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-01
- Public Version
- 2
- Public Version Date
- 2022-07-28
- Public Version Status
- Update
- Public Device Record Key
- fe7dd9bc-670a-428c-a0b2-cd18eccc821f
- Distribution End Date
- 2022-01-01
Device Description
REMI Tablet
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35626 | Electroencephalography telemetric monitoring system | An assembly of devices designed to continuously measure and wirelessly transmit electroencephalographic (EEG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08600053881650 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203827 | 000 |