FDA UDI
In Commercial Distribution
🇺🇸 United States
ATLAS Power Isolator 110VAC
DI: 00850011306987
·
Model: 110VAC
·
NEURALYNX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ATLAS Power Isolator 110VAC
- Primary DI
- 00850011306987
- Version / Model
- 110VAC
- Catalog Number
- 31-0607-0008
- Company Name
- NEURALYNX, INC.
- Labeler DUNS
- 933200842
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-11
- Public Version
- 1
- Public Version Date
- 2024-12-19
- Public Version Status
- New
- Public Device Record Key
- 3cd7cf32-15be-44c6-80e3-8c427d5cf598
Device Description
An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patient leakage current to an acceptable level.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16936 | Uninterruptible power supply system | An assembly of static devices, commonly known as an uninterruptible power supply (UPS), that is connected to the line power system of a hospital or institution to provide an independent continuous supply of electrical power, without delay, whilst the backup generators start. It will supply selected areas of high importance [i.e., operating theatres, the intensive care unit (ICU), the information technology (IT) department] for a limited period of time during the failure of the mains electricity (AC-power) supply. It will consist of a large set of dedicated batteries, battery chargers, and electronics that monitor and switch over to this system when a failure in the line-power has occurred. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011306987 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110967 | 000 |