Identity

Trade Name
FMT FDA UDI
Generic Name
General-purpose patient temperature probe, reusable FDA UDI
Device Name
Reusable ECG - EKG Cables and Leadwires FDA UDI
Model / Reference
E204-5060/0I FDA UDI
Description
Reusable ECG - EKG Cables and Leadwires FDA UDI

Identifiers

Primary DI / UDI-DI
08698870329523 FDA UDI
FDA Product Code
IKD FDA UDI
GMDN Term
General-purpose patient temperature probe, 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: General-purpose patient temperature probe, 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 General-purpose patient temperature probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI a31cf6e4-f229-49e1-864e-16f204574af8 35 fields · synced Jun 8, 2026