FDA.reportPublic FDA data

MediChoice

Primary DI
10885632116629
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
MC1710H
Device description
Electrode Defibrillation Electrocardiogram Radiolucent Vinyl Laminated Foam Conductive Foil Adhesive Hydrogel Pacing Equal To Phillips Dp2 Amp Dp6 Amp M3713A Adult Not Made With Natural Rubber Latex MediChoice
Published
2018-06-15
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
MLNElectrode, electrocardiograph, multi-function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLNElectrode, Electrocardiograph, Multi-FunctionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632116627PackageGS110In Commercial Distribution
10885632116629PrimaryGS10
20885632116626Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563211662750885632116627
1088563211662910885632116629
2088563211662620885632116626

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive skin pad, single-useA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Fahrenheit104 Degrees Fahrenheit
Special Storage Condition, Specify00
Special Storage Condition, Specify00Do not store at over 68 degrees F for greater than four monthes

Regulatory Flags#

DUNS number
007941230
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632522543SurgiTrackSM450030A7E12026-06-04
10885632522512SurgiTrackSM45004591012026-06-03
10885632522222SurgiTrackSM45005945A12026-06-01
10885632522109SurgiTrackSM4501306C092026-05-29
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00009336010080Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
00009336010097Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010085Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010092Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
10888277634893MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634909MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634961MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634985MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634992MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635005MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635012MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635029MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635036MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635050MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635067MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635074MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635081MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635098MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635104MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
00326053105456Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105463Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105470Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105555Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
10326053105453Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105460Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105477Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105552Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
00009336009497Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009503Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009510Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17