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Reusable ECG Lead Wires for GE

FDA UDI

Class II (US FDA UDI)

by Apk Technology

Identity

Trade Name
Reusable ECG Lead Wires for GE FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Model / Reference
10352 FDA UDI

Identifiers

Primary DI / UDI-DI
06946725528105 FDA UDI
FDA Product Code
IKD FDA UDI
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1175 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic lead set, reusable

Reusable ECG Lead Wires for GE by Apk Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apk Technology

Sources (1)

  • FDA UDI 31422f71-2fe9-4c95-b8b5-77a123526bf4 32 fields · synced May 30, 2026