Identity
- Trade Name
- Trulink FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- ELECTRODE,NEONATAL,PRE-WIRED,POUCH,3/ST FDA UDI
- Model / Reference
- NEO ELECTRODES FDA UDI
- Description
- ELECTRODE,NEONATAL,PRE-WIRED,POUCH,3/ST FDA UDI
Identifiers
- Catalog Number
- 015-0244-00 FDA UDI
- Primary DI / UDI-DI
- 10841522102509 FDA UDI
- 510(k) Number
- K103142 FDA UDI
- FDA Product Code
- DSI FDA UDI
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic electrode, single-use
Trulink by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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- SWAROMED — TYROLMED GmbH · Class II
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Cleared under the same submission
K103142 also covers:
- TruLink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), 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
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI 1cd6bf9c-8991-46d2-8e51-90d4dbf38610 36 fields · synced May 30, 2026