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Kendall ECG Leads

FDA UDI

Class II (US FDA UDI)

by Renu Medical, Inc

Identity

Trade Name
Kendall ECG Leads FDA UDI
Generic Name
Electrocardiographic lead set, reprocessed FDA UDI
Device Name
Cardinal Health Kendall Philips INTEL TELE LEAD SET WITH SHOWER SHIELD 5 Lead 5 Pin 50in FDA UDI
Model / Reference
RM-33114N FDA UDI
Description
Cardinal Health Kendall Philips INTEL TELE LEAD SET WITH SHOWER SHIELD 5 Lead 5 Pin 50in FDA UDI

Identifiers

Primary DI / UDI-DI
00816317024291 FDA UDI
FDA Product Code
IKD FDA UDI
GMDN Term
Electrocardiographic lead set, reprocessed 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

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiographic lead set, reprocessed

Kendall ECG Leads by Renu Medical, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, reprocessed.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Renu Medical, Inc

Sources (1)

  • FDA UDI 001a50ac-9738-499e-8533-75b19fbed8d6 33 fields · synced May 30, 2026