FDA UDI
In Commercial Distribution
🇺🇸 United States
PMRU-S KIT
DI: B25972000
·
Model: 7200
·
EMERGE DIAGNOSTICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PMRU-S KIT
- Primary DI
- B25972000
- Version / Model
- 7200
- Company Name
- EMERGE DIAGNOSTICS LLC
- Labeler DUNS
- 078787134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-26
- Public Version
- 4
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- dc44d308-3794-4415-b2b1-6abcbdb4db13
Device Description
Electrical diagnostic functional assessment, combining range of motion, functional capacity, and electromyography testing
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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| OAL | Exercise Equipment, Powered, Emg-Triggered | Physical Medicine | 890.1375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37794 | Electromyography monitor | An electrically-powered device designed to continuously measure electrical signals from a patient’s skeletal muscle and display/record the signals as an electromyograph (EMG) to evaluate brain/nerve function, typically during a surgical procedure. It includes a processing unit with a display intended to be used with EMG leads/electrodes; it may also include data interpretation and/or telemetry features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B25972000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123902 | 000 |