ECG Patient Cable 590412

GUDID 00816396021631

ECG Patient Cable, Shielded, 3-Lead, AHA, 40 in

IVY BIOMEDICAL SYSTEMS, INC.

Electrocardiographic lead set, reusable
Primary Device ID00816396021631
NIH Device Record Key3d66eae6-e288-4355-8cbe-47bf3b28fb99
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG Patient Cable
Version Model Number590412
Catalog Number590412
Company DUNS109132019
Company NameIVY BIOMEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com

Device Dimensions

Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch
Length40 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100816396021631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

On-Brand Devices [ECG Patient Cable]

00816396022294ECG Patient Cable, Shielded, 3 Lead, AHA-IEC, 1.5M
00816396021716ECG Patient Cable, Shielded, 4-Lead, IEC, 10 ft
00816396021679ECG Patient Cable, Shielded, 4-Lead, AHA, 10 ft
00816396021631ECG Patient Cable, Shielded, 3-Lead, AHA, 40 in
00816396021617ECG Patient Cable, Shielded, 3-Lead, IEC, 40 in
00816396021594ECG Patient Cable, Shielded, 3-Lead, IEC, 10 ft
00816396021570ECG Patient Cable, Shielded, 3-Lead, AHA, 10 ft
00816396022829ECG Trunk Cable, Shielded, 3 Lead, AHA/IEC, 40 in
00816396022713ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 10 ft
00816396022706ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 5 ft
00816396022577ECG Trunk Cable MRI, 4 Lead, Single pin, 40 in, AHA/IEC
00816396022560ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 40 in
00816396022553ECG Trunk Cable MRI, 4 Lead, Single pin, 40 in

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