Home GUDID 00860012964819 WHOOP ECG Feature
Primary DI 00860012964819
Brand WHOOP ECG Feature
Company Whoop, Inc.
Model 1.x
Published 2025-06-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name QDA Electrocardiograph Software For Over-The-Counter Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QDA Electrocardiograph Software For Over-The-Counter Use Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860012964819 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860012964819 00860012964819 860012964819 0860012964819
GMDN Terms# Term, Definition table Term Definition Electrocardiograph, home-use A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.
Regulatory Flags# DUNS number 079151198 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices Sharing Product Codes#