Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor

Primary DI
00616784710327
Brand
Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor
Company
Dynarex Corporation
Model
7103
Device description
USE: Application for ECG monitoring or diagnosis with the connected equipment as medical sensors. INSTRUCTIONS: 1. Patient's skin should be clean and dry and free of excessive hair. 2. Remove electrode from backing material. 3. Press electrode to skin around the outer edge. Continue to move pressure toward the center for best adhesive. 4. Attach lead wire to the electrode, START ECG PROCEDURE. CAUTIONS: 1. Only for hospital or physician. 2. Keep any unused electrode in the original recloseable pouch. 3. Electrode use not recommended for more than 72 hours.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00616784710334PackageGS112In Commercial Distribution
00616784710327PrimaryGS10
00616784710310Unit of UseGS10
00810180846790Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784710334006167847103346167847103340616784710334
00616784710327006167847103276167847103270616784710327
00616784710310006167847103106167847103100616784710310
00810180846790008101808467908101808467900810180846790

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, 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, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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