System Cable

FDA UDI

Class II (US FDA UDI)

by Kestra Medical Technologies, Inc.

Identity

Trade Name: System Cable FDA UDI
Generic Name: Electrocardiograph, home-use FDA UDI
Device Name: Provides the connection between an ASSURE Garment and a Battery FDA UDI
Model / Reference: 80500-003 FDA UDI
Description: Provides the connection between an ASSURE Garment and a Battery FDA UDI

Identifiers

Catalog Number: 80500-003 FDA UDI
Primary DI / UDI-DI: 00840241600337 FDA UDI
510(k) Number: K233864 FDA UDI
FDA Product Code: MWJ FDA UDI
GMDN Term: Electrocardiograph, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiograph, home-use

System Cable by Kestra Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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TelePatch Cardiac Monitor — MEDICOMP, INC. · Class II
KardiaMobile Card — AliveCor · Class II
Coala Heart Monitor US Rx — Coala-Life AB · Class II

Cleared under the same submission

K233864 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Kestra Medical Technologies, Inc.

Sources (1)

FDA UDI 6bdf0e0a-ac4d-4317-8203-45b650917642 37 fields · synced Jun 9, 2026