Identity
- Trade Name
- Bio Protech FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- RGEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups FDA UDI
- Model / Reference
- RGEEG-20 (Lifelines) FDA UDI
- Description
- RGEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817120021217 FDA UDI
- 510(k) Number
- K153019 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electroencephalograph
Bio Protech by Bio Protech Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Natus — Natus Neurology Incorporated · Class II
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Cleared under the same submission
K153019 also covers:
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, 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
- Bio Protech Usa, Inc.
Sources (1)
- FDA UDI 00131b29-acf3-451f-94ca-6ce7632a4108 35 fields · synced Jun 8, 2026