FDA.reportPublic FDA data

ECG Snap Electrodes

Primary DI
00616784710334
Brand
ECG Snap Electrodes
Company
DYNAREX CORPORATION
Model
7103
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00616784710334PackageGS112In Commercial Distribution
00616784710327PrimaryGS10
00616784710310Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

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

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22
00840117311572Resp-O2 Oxygen Supply Tubing332022021-04-22
00840117311596Resp-O2 Oxygen Supply Tubing332032021-04-22
00840117311619Resp-O2 Oxygen Supply Tubing332042021-04-22
00840117311633Resp-O2 Oxygen Supply Tubing332052021-04-22
00840117311657Resp-O2 Oxygen Supply Tubing332062021-04-22
00840117311671Resp-O2 Oxygen Supply Tubing332072021-04-22
00840117311695Resp-O2 Oxygen Supply Tubing332082021-04-22
00840117318625Resp-O2 Oxygen Tubing Inline Water Traps333022021-04-22
00840117318632Resp-O2 Oxygen Tubing 22mm I.D. x 5-7 mm Tapered Nipple Adaptors333032021-04-22
00840117318649Resp-O2 Oxygen Tubing 5-7 mm End Adaptors333042021-04-22
00840117318663Resp-O2 Oxygen Tubing Y Adaptors333062021-04-22
00840117318670Resp-O2 Oxygen Tubing Nut Nipple Adaptors333072021-04-22
00840117318687Resp-O2 Oxygen Tubing Nut Nipple Swivel Adaptors333082021-04-22
00840117318694Resp-O2 Portable Oxygen Liter Meters333092021-04-22
00840117342361Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) O2 and CO2 Tubing331982025-06-09
00840117342408Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) O2 and CO233199-F2025-06-09
00840117324008Resp-O2 Compressor, 50 PSI339522022-07-11
00840117310254Resp-O2 Oxygen Concentrator, 5L339502022-05-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035283055Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283062Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20