FDA.reportPublic FDA data

Choicemmed

Primary DI
06942820462320
Brand
Choicemmed
Company
Beijing Choice Electronic Technology Co., Ltd.
Model
MD100A1-F
Device description
Choicemmed Handheld ECG Monitor MD100A1-F
Published
2023-08-23
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942820462320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942820462320069428204623206942820462320

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA device intended to be used by a healthcare professional in a clinical setting 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 is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526882823
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942820462535BLUE JAYBJ2401052026-01-23
00846841010262mibestCHP1C12021-09-24
00846841010279mibestCHP1C1-Gel2021-09-24
06942820462511VIEW O2180-50572025-12-23
06942820462528OxywatchDSI-DSFP-22025-12-23
00846841092527ChoiceMMedOxyWatch C292025-09-29
00846841092695ChoiceMMedMD300CN568R2025-09-24
00846841060830Henry Schein112-70632016-09-29
00846841060724ChoiceMMedMDN1042018-05-29
00846841060762ChoiceMMedMDN1052016-09-28
00846841092596mibestIBH-0012025-07-23
00846841091599mibestMD300C572025-07-22
00846841092565ChoiceMMedMD300CI218R2025-07-22
00846841092701mibestMD300C562025-07-22
00846841092947ChoiceMMedOxyWatch C2052025-07-22
00846841092954ChoiceMMedMD300CN550R2025-07-22
06942820462504Choicemmed MD300W6282025-07-22
00846841092589mibestNA-0022025-07-18
06942820462368ChoicemmedMD300CI218R2025-04-27
06942820462375ChoicemmedMD300CI216R2025-04-27

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Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DPS2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Devices, Inc.DPS2026-04-03
00195278620873MACGe Medical Systems Information Technologies, Inc.DPS2026-03-31
10843997011003Radius VSMMASIMO CORPORATIONDPS2026-02-23