HeartCheck Palm HC-PM10

GUDID 00812324000136

HeartCheck Palm Portable ECG

CardioComm Solutions, Inc

Electrocardiographic monitor
Primary Device ID00812324000136
NIH Device Record Keyd96f37af-5d2b-4ef8-bdf5-a30d29ed4c4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartCheck Palm
Version Model NumberHC-PM10
Catalog NumberHC-PM10
Company DUNS251043907
Company NameCardioComm Solutions, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100812324000136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-30

Devices Manufactured by CardioComm Solutions, Inc

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00812324000242 - GEMS Win AutoAttendant2023-11-17 GEMS Win AutoAttendant
00812324000259 - GEMS Win Air2023-11-17 GEMS Win Air
00812324000228 - GEMS Win TTM & ICD2023-11-16 GEMS Win ARR TTM & Full Pacing
00812324000266 - GEMS Win HL72023-11-16 HL7 plug-in module for GEMS Win
00812324000044 - HeartCheck CardiBeat2019-03-12 HeartCheck CardiBeat portable ECG monitor
00812324000020 - HeartCheck BT PEN Handheld ECG2018-07-06 Bluetooth PEN Handheld ECG

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