FDA.reportPublic FDA data

Medline

Primary DI
10888277254176
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYKM1027
Catalog number
DYKM1027
Device description
BAG C OPEN HEART KIT
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277254177PackageGS120In Commercial Distribution
10888277254176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827725417740888277254177
1088827725417610888277254176

GMDN Terms#

Term, Definition table
TermDefinition
Multifunction cardiac treatment electrodeAn electrical conductor designed to be applied to an adult and/or paediatric patient for automatic or manual defibrillation, external pacing, and cardioversion through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses (e.g., defibrillator); it commonly will also be used for electrocardiographic monitoring. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24
10653160395720MEDLINEDYNDC3637DYNDC36372026-10-24
10653160395751MEDLINEECVC8657ECVC86572026-10-24
10653160395782MEDLINEEBSI1426BEBSI1426B2026-10-24
10653160395799MEDLINEECVC2440CECVC2440C2026-10-24
10653160395805MEDLINEEBSI1687AEBSI1687A2026-10-24
10653160395812MEDLINEEBSI1356AEBSI1356A2026-10-24
10653160395850MEDLINEECVC7295AECVC7295A2026-10-24
10653160395867MEDLINEEBSI1590AEBSI1590A2026-10-24
10653160395881MEDLINEECVC2770AECVC2770A2026-10-24
10653160395911MEDLINEEBSI1529AEBSI1529A2026-10-24
10653160395959MEDLINEDYNDV2823DYNDV28232026-10-24
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10884389194775MEDLINEMDS9911MDS99112016-10-14
10884389194799MEDLINEMDS9911MQMDS9911MQ2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160395744CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-10-24
10653160395751MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395799MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395850MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395867MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395881MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395959MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10198956433113CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956460942CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956544123CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956556065CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956557055CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956557642CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956562745CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956571129CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956577565CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956577589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956578890CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956578951CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956579118CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956583863CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956584709CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956585591CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956586727CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956586956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956590939CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956591776CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956595781CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956601079CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956602182CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23