Identity
- Trade Name
- Bio Protech FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- DEEG-A-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use FDA UDI
- Model / Reference
- DEEG-A-15 (Lifelines) FDA UDI
- Description
- DEEG-A-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817120021156 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
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
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
- 128-channel EEG cap (L) — Megin Oy · Class II
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- Zeto ONE Head Unit - Small — ZETO INC · Class II
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 c0458718-8ac1-49b4-bb07-be38f4bb6ee8 35 fields · synced Jun 6, 2026