590168

GUDID 10653405005315

IVY BIOMEDICAL ECG LEADWIRES

Conmed Corporation

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable
Primary Device ID10653405005315
NIH Device Record Key7f587457-cdbe-43f4-80cc-3770fc7d97eb
Commercial Distribution Discontinuation2022-06-16
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number590168
Catalog Number590168
Company DUNS071595540
Company NameConmed Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110653405005315 [Primary]

FDA Product Code

IKDCABLE, ELECTRODE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-17
Device Publish Date2016-10-14

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10845854044322 - CONMED2024-03-28 Pin, Blunt, 2.4mm
20845854031619 - SEQUENT2024-03-28 SEQUENT DISPOSABLE SUTURE CUTTER
40845854061313 - PLUMEPEN2024-03-28 PlumePen Pro Disposable Capture Port Tips 4 in (10.16 cm)
40845854061337 - PLUMEPEN2024-03-28 PlumePen Pro Disposable Capture Port Tips 6 in (15.24 cm)
20653405012006 - EXCEL2024-03-27 EXCEL 10FT (3.05M) INSUFFLATION TUBING SET WITH 0.1 MICRON FILTER
20653405012013 - EXCEL2024-03-27 EXCEL 10FT (3.05M) INSUFFLATION TUBING SET WITH 0.1 MICRON FILTER

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