FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040003364
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9007028
Catalog number
9007028
Device description
ELECTRODE MONITOR HSI
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K041954000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041954000DISPOSABLE MONITORING ELECTRODESShanghai Intco Electrode Manufacturing Co., Ltd.2004-09-15DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040003364PackageGS120In Commercial Distribution
00304040003367PrimaryGS10
20304040003361Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404000336410304040003364
00304040003367003040400033673040400033670304040003367
2030404000336120304040003361

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid Sunlight and Keep Dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05
10304040194307Henry Schein570570757057072026-10-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20885380213202KendallCardinal Health 200, LLCDRX2026-08-18
10850078465006NIKOTRACENIKOMED USADRX2026-08-17
10850078465013NIKOTRACENIKOMED USADRX2026-08-17
10850078465020NIKOTRACENIKOMED USADRX2026-08-17
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
00860002238500Piccolo MedicalPiccolo Medical, Inc.DRX2026-05-06
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
00860002238586Piccolo MedicalPiccolo Medical, Inc.DRX2025-11-07
10841522130755Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCDRX2024-06-07
20192253016632KendallCardinal Health 200, LLCDRX2024-02-28
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253016830KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017813KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
20192253016748KendallCardinal Health 200, LLCDRX2021-05-19
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017349KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20