Identity
- Trade Name
- Premium Study Kit FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Single use, premium study kit extra extra large. FDA UDI
- Model / Reference
- Extra Extra Large - Single FDA UDI
- Description
- Single use, premium study kit extra extra large. FDA UDI
Identifiers
- Catalog Number
- 602-0114 FDA UDI
- Primary DI / UDI-DI
- B14360201141 FDA UDI
- 510(k) Number
- K042039 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroencephalograph
Premium Study Kit by Cleveland Medical Devices Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042039 also covers:
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- Premium Study Kit — Cleveland Medical Devices Inc.
- ReadyRip Belt — Cleveland Medical Devices Inc.
- ReadyRip Belt — Cleveland Medical Devices Inc.
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- Sapphire — Cleveland Medical Devices Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cleveland Medical Devices Inc.
Sources (1)
- FDA UDI 07eba69a-25d2-4fc6-b30f-80fd1b3f4dc7 35 fields · synced May 30, 2026