FDA.reportPublic FDA data

CardioMem

Primary DI
04250903203381
Brand
CardioMem
Company
getemed Medizin- und Informationstechnik AG
Model
CM 4000 B
Device description
The CardioMem CM 4000 and CM 4000 B digital Holter recorders are intended to continuously record ECG data. The recorders per-form no cardiac analysis by themselves and are intended to be used with an ECG analysis software package. The recorded data are down-loaded to a PC for analysis and subsequent evaluation by a trained physician or health care professional.
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122272000CARDIOMEMGetemed Medizin- Und Informationstechnik AG2013-03-28MWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250903203381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250903203381042509032033814250903203381

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
331682898
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250903200724SEER 100024 hour - Korean2067634-0672021-06-17
04250903200731SEER 100048 hour - Korean2067634-0682021-06-17
04250903200748SEER 1000 7 day - Korean2067634-0692021-06-17
04250903200991SEER 100024 Hour - Korean2067634-0672025-03-14
04250903201011SEER 100048 Hour - Korean2067634-0682025-03-14
04250903201035SEER 1000 7 Day - Korean2067634-0692025-03-14
04250903200878SEER 100024 hour - UNI2067634-0582025-03-04
04250903200892SEER 100048 hour - UNI2067634-0592025-03-04
04250903200915SEER 1000 7 day - UNI2067634-0602025-03-04
04250903201080SEER 100024 hour - CA2067634-1752025-03-04
04250903201103SEER 100048 hour - CA2067634-1762025-03-04
04250903201127SEER 1000 7 day - CA2067634-1772025-03-04
04250903201585ECG Cable for SEER 10005 Leads, 75 cm, IEC Color Code2104810-0012019-09-12
04250903201592ECG Cable for SEER 10007 Leads, 75 cm, IEC Color Code2104811-0012019-09-12
04250903201608ECG Cable for SEER 10005 Leads, 105 cm, IEC Color Code2104812-0012019-09-12
04250903201615ECG Cable for SEER 10007 Leads, 105 cm, IEC Color Code2104813-0012019-09-12
04250903201622ECG Cable for SEER 10005 Leads, 75 cm, AHA Color Code2104814-0012019-09-12
04250903201639ECG Cable for SEER 10007 Leads, 75 cm, AHA Color Code2104815-0012019-09-12
04250903201646ECG Cable for SEER 10005 Leads, 105 cm, AHA Color Code2104816-0012019-09-12
04250903201653ECG Cable for SEER 10007 Leads, 105 cm, AHA Color Code2104817-0012019-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf BoxSibel Health Inc.MWJ2025-12-17
10841522131349Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131356Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131363Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131387Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131394Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131400Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131370Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-01
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
B353UB12511UbiqVue HolterLifesignals, Inc.MWJ2025-04-22
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.MWJ2025-04-02
00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.MWJ2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.MWJ2025-04-02
00860004541745ANNE ChestSibel Health Inc.MWJ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.MWJ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.MWJ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.MWJ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.MWJ2025-03-26
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201103SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04