Identity
- Trade Name
- Klear-Trace FDA UDI
- Generic Name
- Neonatal electrocardiographic electrode FDA UDI
- Device Name
- Long Term 5 Lead Electrode FDA UDI
- Model / Reference
- 2500 FDA UDI
- Description
- Long Term 5 Lead Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813880023126 FDA UDI
- 510(k) Number
- K861364 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Neonatal electrocardiographic electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neonatal electrocardiographic electrode
Klear-Trace by Trinity Medical Devices Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neonatal electrocardiographic electrode.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- NeoLead® — Neotech Products LLC · Class II
- BlueSensor BRSECG Electrodes — Ambu A/S · Class II
- BlueSensor NEOXECG Electrodes — Ambu A/S · Class II
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
- Trinity Medical Devices Inc.
Sources (1)
- FDA UDI 97099434-acd1-4984-a82e-c98c383419b4 34 fields · synced May 30, 2026