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Trulink

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Trulink FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Device Name
LDWR,INDV,DIN,PINCH,GREEN,102CM/40IN,AAMI,3/PK FDA UDI
Model / Reference
90470 FDA UDI
Description
LDWR,INDV,DIN,PINCH,GREEN,102CM/40IN,AAMI,3/PK FDA UDI

Identifiers

Catalog Number
012-0296-32 FDA UDI
Primary DI / UDI-DI
10841522101670 FDA UDI
510(k) Number
K103142 FDA UDI
FDA Product Code
DSI FDA UDI
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Trulink by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K103142 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI 70ff244c-5dde-4ac7-87a1-7c67f1a9ee70 37 fields · synced Jun 8, 2026