FDA.reportPublic FDA data

NA

Primary DI
10653405005261
Brand
NA
Company
Conmed Corporation
Model
590198
Catalog number
590198
Device description
IVY BIOMEDICAL ECG CABLES
Published
2016-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
IKDCABLE, ELECTRODE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405005261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065340500526110653405005261

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00845225012946IntraSight PlusPhilips Image Guided Therapy CorporationDSA2026-05-26
07613365003925SCHILLERSchiller AGDSA2026-05-26
07613365003932SCHILLERSchiller AGDSA2026-05-26
07613365003949SCHILLERSchiller AGDSA2026-05-26
07613365003956SCHILLERSchiller AGDSA2026-05-26
07613365004199SCHILLERSchiller AGDSA2026-05-26
07613365004205SCHILLERSchiller AGDSA2026-05-26
07613365004212SCHILLERSchiller AGDSA2026-05-26
07613365004229SCHILLERSchiller AGDSA2026-05-26
20192253019992KendallCardinal Health 200, LLCIKD2026-05-26
06946725550748APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725555316APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725571477APKAPK Technology Co.,Ltd.IKD2026-05-22
10653405063797CONMEDConmed CorporationDSA2026-03-24
20653405017759CONMEDConmed CorporationIKD2026-03-24
20653405017766CONMEDConmed CorporationDSA2026-03-24
20653405019777CONMEDConmed CorporationDSA2026-03-24
20653405022821CONMEDConmed CorporationDSA2026-03-24
20653405022838CONMEDConmed CorporationDSA2026-03-24
20653405022951CONMEDConmed CorporationDSA2026-03-24
20653405023057CONMEDConmed CorporationDSA2026-03-24
20653405023071CONMEDConmed CorporationDSA2026-03-24
20653405023163CONMEDConmed CorporationDSA2026-03-24
20653405023170CONMEDConmed CorporationDSA2026-03-24
20653405023385CONMEDConmed CorporationDSA2026-03-24
20653405023545CONMEDConmed CorporationDSA2026-03-24
20653405034701CONMEDConmed CorporationDSA2026-03-24
20653405036194CONMEDConmed CorporationDSA2026-03-24
20653405059858CONMEDConmed CorporationDSA2026-03-24