Tapsystem 8002A-9999

GUDID 00856233005158

A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged).

CARDIOCOMMAND, INC.

External pacemaker, transoesophageal pacing
Primary Device ID00856233005158
NIH Device Record Key865465ea-4f70-4f9f-9cd3-3f880ac36d19
Commercial Distribution StatusIn Commercial Distribution
Brand NameTapsystem
Version Model Number2A re-man'd, unpackaged
Catalog Number8002A-9999
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 Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100856233005158 [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 Date2015-07-22

On-Brand Devices [Tapsystem]

00856233005158A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged
00856233005073A cable used to connect a patient to a Model 2A pulse generator system for the treatment of card
00856233005066A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit).

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