Model 7A 0406

GUDID 00856233005110

Interface cable between 7A Stimulator and Model 3 preamplifier.

CARDIOCOMMAND, INC.

External pacemaker, transoesophageal pacing
Primary Device ID00856233005110
NIH Device Record Keybec2048b-1022-4a6c-a715-6fa576a76189
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 7A
Version Model Number7A/Mod 3 Interface cable
Catalog Number0406
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

Customer Support Contacts

Phone(800) 231-6370
Emailcconley@CardioCommand.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856233005110 [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 Number4
Public Version Date2018-10-05
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.

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