FDA UDI
In Commercial Distribution
🇺🇸 United States
ATLAS Rackmounted Power Isolator
DI: 00850011306239
·
Model: ATLAS Rackmounted Power Isolator
·
NEURALYNX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ATLAS Rackmounted Power Isolator
- Primary DI
- 00850011306239
- Version / Model
- ATLAS Rackmounted Power Isolator
- Catalog Number
- 31-0607-0015
- 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
- b8bc6579-680d-455f-b545-10d228f4c3cc
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 in a rack mounted form factor.
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 | 00850011306239 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110967 | 000 |