FDA.reportPublic FDA data

Levmed ECG 12 Lead Electrodes belt

Primary DI
07290016423051
Brand
Levmed ECG 12 Lead Electrodes belt
Company
LEVMED LTD
Model
ARh
Catalog number
11061/h-LM
Device description
Dedicated ECG Electrode Belt with Handles. D-Type With Screws Connector
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016423051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016423051072900164230517290016423051

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, reusableA noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+011972544361672info@levmed.net

Regulatory Flags#

DUNS number
600401224
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016423020Levmed ECG 12 Lead Electrodes belt 6UsA-11002n-LM2023-07-14
07290016423068Levmed ECG 12 Lead Electrodes belt ARsA-11061/s-AL2023-07-14
07290016423266Levmed ECG 12 Lead Electrodes belt ALBh11005/h-AL2023-07-14
07290016423273Levmed ECG 12 Lead Electrodes belt ALBs11005/s-AL2023-07-14

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Primary DI, Brand, Company table
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