Model 7A 8021

GUDID 00856233005127

Patient lead wire for use with the Model 7A stimulator; black, left arm.

CARDIOCOMMAND, INC.

Electrocardiographic lead set, reusable
Primary Device ID00856233005127
NIH Device Record Keybece191c-652d-4c45-93d8-c77b587645ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 7A
Version Model NumberLeft arm patient lead wire
Catalog Number8021
Company DUNS800214827
Company NameCARDIOCOMMAND, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856233005127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPASystem, Esophageal Pacing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-04-03

On-Brand Devices [Model 7A]

00856233005172Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed
00856233005165Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed
00856233005134Patient lead wire for use with the Model 7A stimulator; white, right arm.
00856233005127Patient lead wire for use with the Model 7A stimulator; black, left arm.
00856233005110Interface cable between 7A Stimulator and Model 3 preamplifier.
00856233005103Instrument cable for 7A Stimulator or Model 3 preamp.

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