FDA.reportPublic FDA data

ECG Snap Electrodes

Primary DI
00616784710129
Brand
ECG Snap Electrodes
Company
Dynarex Corporation
Model
7101
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093327000INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.2010-05-10DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784710136PackageGS1200In Commercial Distribution
00616784710129PrimaryGS10
00616784710112Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784710136006167847101366167847101360616784710136
00616784710129006167847101296167847101290616784710129
00616784710112006167847101126167847101120616784710112

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
3
Lot or batch
true

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00840117316577Resp-O2 EtCO2 Nasal Sampling Cannula331802021-04-22
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Primary DI, Brand, Company table
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