FDA UDI
In Commercial Distribution
🇺🇸 United States
Cumulus Functional Neurophysiology Platform
DI: 05061027610011
·
Model: CN-T5H
·
CUMULUS NEUROSCIENCE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cumulus Functional Neurophysiology Platform
- Primary DI
- 05061027610011
- Version / Model
- CN-T5H
- Catalog Number
- CN-T5H
- Company Name
- CUMULUS NEUROSCIENCE LIMITED
- Labeler DUNS
- 220568006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-05
- Public Version
- 1
- Public Version Date
- 2024-06-13
- Public Version Status
- New
- Public Device Record Key
- 3b1714c1-aba5-4759-ab86-42809b7150da
Device Description
Cumulus EEG Headset and Mobile Application
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63131 | Electroencephalographic electrode cap, reusable | An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap with integrated (and often removable) scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05061027610011 | GS1 |
Customer Contacts
- Phone
- +442892646600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221963 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity