FDA.reportPublic FDA data

Tapsystem

Primary DI
00856233005158
Brand
Tapsystem
Company
CARDIOCOMMAND, INC.
Model
2A re-man'd, unpackaged
Catalog number
8002A-9999
Device description
A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged).
Published
2015-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPASystem, Esophageal Pacing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPASystem, Esophageal PacingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P840002007
P840002012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P840002007STAT-PACE IICardiocommand, Inc.1986-04-30LPA
P840002012STAT-PACE IICardiocommand, Inc.1986-04-30LPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856233005158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856233005158008562330051588562330051580856233005158

GMDN Terms#

Term, Definition table
TermDefinition
External pacemaker, transoesophageal pacingA device designed to generate electrical cardiac pacing impulses from an external pulse generator (EPG), located outside the body, and transmit them to the heart via its leads that are placed in the oesophagus. The device is used for temporary stimulation of the heart.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature40 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 231-6370cconley@CardioCommand.com

Regulatory Flags#

DUNS number
800214827
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856233005127Model 7ALeft arm patient lead wire80212015-04-03
00856233005134Model 7ARight arm patient lead wire80232015-04-03
10856233005063Tapsystem2A, single pack8002A2015-07-22
10856233005155Tapsystem2A re-man'd, single pack8002A-99992015-07-22
10856233005162Model 7ASingle pack01012015-04-03
10856233005179Model 7ARe-manufactured, single pack0101-99992015-04-03
00856233005066Tapsystem2A, unpackaged8002A2015-07-22
00856233005110Model 7A7A/Mod 3 Interface cable04062015-04-03
00856233005165Model 7AUnpackaged01012015-04-03
00856233005172Model 7ARe-manufactured, unpackaged0101-99992015-04-03
10856233005186Model 3Single pack01042015-04-03
10856233005193Model 3Re-manufactured, single pack0104-99992015-04-03
00856233005004Tapscope550, single pack2002015-04-03
00856233005011Tapscope550F, single pack2502015-04-08
00856233005028Tapscope210, single pack1002015-04-03
00856233005035Tapscope210-S, single pack1022015-04-03
00856233005042Tapcath205, single pack1802015-04-03
00856233005059Tapcath1600, single pack16002015-07-22
00856233005073Tapsystem2A Patient Cable20102015-07-22
00856233005080EP ConnectTapcath8031-00012015-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10856233005063TapsystemCARDIOCOMMAND, INC.LPA2015-07-22
10856233005155TapsystemCARDIOCOMMAND, INC.LPA2015-07-22
00856233005066TapsystemCARDIOCOMMAND, INC.LPA2015-07-22
00856233005073TapsystemCARDIOCOMMAND, INC.LPA2015-07-22
10856233005162Model 7ACARDIOCOMMAND, INC.LPA2015-04-03
10856233005179Model 7ACARDIOCOMMAND, INC.LPA2015-04-03
10856233005186Model 3CARDIOCOMMAND, INC.LPA2015-04-03
10856233005193Model 3CARDIOCOMMAND, INC.LPA2015-04-03
00856233005103Model 7ACARDIOCOMMAND, INC.LPA2015-04-03
00856233005110Model 7ACARDIOCOMMAND, INC.LPA2015-04-03
00856233005127Model 7ACARDIOCOMMAND, INC.LPA2015-04-03
00856233005134Model 7ACARDIOCOMMAND, INC.LPA2015-04-03
00856233005165Model 7ACARDIOCOMMAND, INC.LPA2015-04-03
00856233005172Model 7ACARDIOCOMMAND, INC.LPA2015-04-03
00856233005189Model 3CARDIOCOMMAND, INC.LPA2015-04-03
00856233005196Model 3CARDIOCOMMAND, INC.LPA2015-04-03