Identity

Trade Name
FMT FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Device Name
Reusable ECG - EKG Cables and Leadwires FDA UDI
Model / Reference
E202-5060/0I FDA UDI
Description
Reusable ECG - EKG Cables and Leadwires FDA UDI

Identifiers

Primary DI / UDI-DI
08698870319609 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic lead set, reusable

Fmt by Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi — 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

Sources (1)

  • FDA UDI 6a68b1f3-5e9a-40c4-bea0-455a3c4370f1 35 fields · synced May 30, 2026