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King of Hearts AF

FDA UDI

Class II (US FDA UDI)

by Lifewatch

Identity

Trade Name
King of Hearts AF FDA UDI
Generic Name
Electrocardiography telemetric monitoring system transmitter FDA UDI
Device Name
King of Hearts Express AF Cardiac Event Recorder FDA UDI
Model / Reference
King of Hearts AF FDA UDI
Description
King of Hearts Express AF Cardiac Event Recorder FDA UDI

Identifiers

Primary DI / UDI-DI
00850725007071 FDA UDI
510(k) Number
K111745 FDA UDI
FDA Product Code
DSH FDA UDI
GMDN Term
Electrocardiography telemetric monitoring system transmitter 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiography telemetric monitoring system transmitter

King of Hearts AF by Lifewatch — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiography telemetric monitoring system transmitter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lifewatch

Sources (1)

  • FDA UDI f93f7839-22d4-4127-a89b-4031e7a9189a 35 fields · synced Jun 6, 2026