HeartCheck Palm

Basic Information

• Brand Name: HeartCheck Palm
• Primary DI: 00812324000136
• Version / Model: HC-PM10
• Catalog Number: HC-PM10
• Company Name: CardioComm Solutions, Inc
• Labeler DUNS: 251043907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d96f37af-5d2b-4ef8-bdf5-a30d29ed4c4c

Device Description

HeartCheck Palm Portable ECG

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35195	Electrocardiographic monitor	A mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812324000136	GS1

Premarket Submissions

Submission Number	Supplement Number
K152863	000