IVY BIOMEDICAL 590322-BC

GUDID 30653405005128

IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES

Conmed Corporation

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use
Primary Device ID30653405005128
NIH Device Record Key3f2b05dd-2741-4960-9d42-3d0bb285af25
Commercial Distribution Discontinuation2021-07-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIVY BIOMEDICAL
Version Model Number590322-BC
Catalog Number590322-BC
Company DUNS071595540
Company NameConmed Corporation
Device Count600
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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
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
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
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405005127 [Unit of Use]
GS110653405005124 [Primary]
GS130653405005128 [Package]
Contains: 10653405005124
Package: CARTON [600 Units]
Discontinued: 2021-07-17
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-19
Device Publish Date2016-10-14

On-Brand Devices [IVY BIOMEDICAL]

30653405005142IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
30653405005135IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
30653405005043IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
10653405004462IVY BIOMEDICAL, ECG CABLES
10653405004448IVY BIOMEDICAL, ECG CABLES
30653405005098IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
10653405004424IVY BIOMEDICAL, ECG CABLES
20653405082559IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
30653405005128IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
30653405005111IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
30653405005104IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
20653405004544IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
10653405004479IVY BIOMEDICAL, ECG CABLES
10653405003489IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
10653405003380IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
10653405003311IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
10653405003250IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES
10653405003120IVY BIOMEDICAL, RADIOTRANSLUCENT ECG ELECTRODES

Trademark Results [IVY BIOMEDICAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IVY BIOMEDICAL
IVY BIOMEDICAL
90367043 not registered Live/Pending
Ivy Biomedical Systems, Inc.
2020-12-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.