Device
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...
Manufacturer
getemed Medizin- und Informationstechnik AG
getemed Medizin- und Informationstechnik AG
Model: CM 4000 B
DI: 04250903203381
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e41db7e7-fdb9-4dc3-b1ea-79621f12359b
Distribution Status:
In Commercial Distribution
DUNS Number:
331682898
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04250903203381
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35162
Name: Electrocardiographic ambulatory recorder
Definition:
An 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).
FDA Product Codes
MWJ
Electrocardiograph, Ambulatory (Without Analysis)
Premarket Submissions
Submission Number:
K122272
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
-25
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
70
Storage Handling - Storage Handling Type:
Storage Environment Temperature