FDA.reportPublic FDA data

ECG Leadwire Set for CM 3000 Series

Primary DI
04250903200243
Brand
ECG Leadwire Set for CM 3000 Series
Company
getemed Medizin- und Informationstechnik AG
Model
5 Leads, 60 cm, Colors: Red, Brown, Black, White,
Catalog number
2014606-038
Device description
The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder).
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022540000CARDIO ID+(RZ153+)Rozinn Electronics, Inc.2002-10-24DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250903200243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250903200243042509032002434250903200243

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49332939420info@getemed.de

Regulatory Flags#

DUNS number
331682898
Device count
1
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250903203381CardioMem CM 4000 B2026-05-01
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

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