Identity
- Trade Name
- Trackit T4 FDA UDI
- Generic Name
- Electroencephalographic ambulatory recorder FDA UDI
- Model / Reference
- T4-32 + BT + WI-FI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060275450530 FDA UDI
- FDA Product Code
- GWL FDA UDIGWQ FDA UDI
- GMDN Term
- Electroencephalographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1835 FDA UDI882.1400 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroencephalographic ambulatory recorder
Trackit T4 by Lifelines Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151600 also covers:
- R-40 — LIFELINES LIMITED
- R-40 — LIFELINES LIMITED
- R-40 — LIFELINES LIMITED
- R-40 — LIFELINES LIMITED
- R-40 — LIFELINES LIMITED
- R-40 — LIFELINES LIMITED
- R-40 — LIFELINES LIMITED
- R-40 (24) — LIFELINES LIMITED
- R-40 (24) — LIFELINES LIMITED
- R-40 (24) — LIFELINES LIMITED
- R-40 (24) — LIFELINES LIMITED
- R-40 (24) — LIFELINES LIMITED
K172271 also covers:
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4 — LIFELINES LIMITED
- Trackit T4A — 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 18b080f7-633d-4461-8414-ae67e87de24c 34 fields · synced Jun 1, 2026