Identity
- Trade Name
- Trackit FDA UDI
- Generic Name
- Electroencephalographic ambulatory recorder FDA UDI
- Model / Reference
- Trackit 12/0 Kit FDA UDI
Identifiers
- Catalog Number
- 2124B FDA UDI
- Primary DI / UDI-DI
- 05060275450233 FDA UDI
- 510(k) Number
- K010460 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Electroencephalographic ambulatory recorder 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electroencephalographic ambulatory recorder
Trackit by Lifelines Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Compumedics Okti — COMPUMEDICS LIMITED · Class II
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- BE Micro Headbox — EB NEURO SPA · Class II
Cleared under the same submission
K010460 also covers:
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
- Trackit — LIFELINES LIMITED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lifelines Limited
Sources (1)
- FDA UDI 33dc5c8c-10ec-4eda-b4ea-49339094024d 35 fields · synced Jun 8, 2026