FDA.reportPublic FDA data

Medichoice

Primary DI
10885632117961
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
MC5400
Device description
Electrode Electrocardiography Tab Resting Radiolucent Not Made With Natural Rubber Latex Non-Sterile MediChoice
Published
2016-09-16
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
20885632117968PackageGS110In Commercial Distribution
50885632117969PackageGS14In Commercial Distribution
10885632117961PrimaryGS10
60885632117966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563211796820885632117968
5088563211796950885632117969
1088563211796110885632117961
6088563211796660885632117966

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid Direct Sunlight, Keep Dry

Regulatory Flags#

DUNS number
007941230
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632541131SurgiTrackSM45005945612026-10-22
10885632417122Halyard555702026-10-21
10885632417146Halyard555722026-10-21
10885632520327HALYARDABC10102026-10-21
10885632520334HALYARDABC10122026-10-21
20885632532129HALYARDABCP10062026-10-21
10885632540776SurgiTrackSM450387ABDC2026-10-19
10885632540844SurgiTrackSM45016406752026-10-19
10885632540851SurgiTrackSM450164E9E92026-10-19
10885632540639SurgiTrackSM450030A8C42026-10-15
10885632540646SurgiTrackSM450030D0722026-10-15
10885632540615SurgiTrackSM450087ABBD2026-10-13
10885632540059SurgiTrackSM4503872A3B2026-10-07
10885632539206SurgiTrackSM450041D1852026-09-29
10885632539039SurgiTrackSM450087473B2026-09-25
10885632538902SurgiTrackSM450048BAEE2026-09-24
10885632537066SurgiTrackSM4501483A7F2026-09-18
10885632537110SurgiTrackSM450070CC682026-09-18
10885632532665SurgiTrackSM450087F5342026-09-04
10885632532726SurgiTrackSM450041DB622026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561006ECG Patient CableINTERNATIONAL BIOMEDICAL, LTD.DRX2026-10-13
19005531000978SkintactLeonhard Lang GmbHDRX2026-10-12
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