FDA.reportPublic FDA data

HeartCheck BT PEN Handheld ECG

Primary DI
00812324000020
Brand
HeartCheck BT PEN Handheld ECG
Company
CardioComm Solutions, Inc
Model
HCEKGBTPEN30
Catalog number
HCEKGBTPEN30
Device description
Bluetooth PEN Handheld ECG
Published
2017-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121009000HEARTCHECK ECG PEN WITH GEMS HOMECardiocomm Solutions, Inc.2012-05-17DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812324000020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812324000020008123240000208123240000200812324000020

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel) but may otherwise include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included. It is intended to be used by a healthcare professional in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251043907
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812324000136HeartCheck PalmHC-PM10HC-PM102017-11-30
00812324000297GEMS Mobile ECGGMGM2025-03-20
00812324000204GEMS Win ArrhythmiaGW-ARRGW-ARR2023-11-09
00812324000211GEMS Win TTMGW-TTMGW-TTM2023-11-09
00812324000242GEMS Win AutoAttendantGW-AAGW-AA2023-11-09
00812324000259GEMS Win AirGW-AIRGW-AIR2023-11-09
00812324000228GEMS Win TTM & ICDGW-TTMICDGW-TTMICD2023-11-08
00812324000266GEMS Win HL7GW-HL7GW-HL72023-11-08
00812324000044HeartCheck CardiBeatHC-WC-01HC-WC-012019-03-04

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