FDA UDI
In Commercial Distribution
🇺🇸 United States
PreOp
DI: 05430000733021
·
Model: v2
·
Clouds of Care
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PreOp
- Primary DI
- 05430000733021
- Version / Model
- v2
- Company Name
- Clouds of Care
- Labeler DUNS
- 371252830
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-22
- Public Version
- 2
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- 67abb55e-ed99-407c-b359-052b5822fe10
Device Description
PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
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 |
|---|---|---|---|---|
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47541 | Bioelectrical signal analysis software | A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05430000733021 | GS1 | ||||
| Previous | 05430000733007 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172858 | 000 |