FDA UDI
In Commercial Distribution
🇺🇸 United States
NQ TMS Coil Cooler
DI: 00860012355433
·
Model: NQv1-CU-01
·
Neuroqore, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NQ TMS Coil Cooler
- Primary DI
- 00860012355433
- Version / Model
- NQv1-CU-01
- Company Name
- Neuroqore, Inc.
- Labeler DUNS
- 119358200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-06
- Public Version
- 1
- Public Version Date
- 2025-08-14
- Public Version Status
- New
- Public Device Record Key
- 0ec29a87-8a11-40d1-8304-5a4902c66bb7
Device Description
Cooling Unit: It is used to ensure that a TMS Applicator does not overheat during TMS treatment, thus preventing risk of burn to the user or the patient.
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
- 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 |
|---|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | Neurology | 882.5805 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61124 | Magnetic neural stimulation system | An assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012355433 | GS1 |
Customer Contacts
- Phone
- 949-397-1333
- [email protected]