FDA.reportPublic FDA data

Micropace

Primary DI
09349714004623
Brand
Micropace
Company
MICROPACE PTY LIMITED
Model
EPS320_StimCor CardiacStimulator
Catalog number
MP3102BT-GE-US, MP3102US, MP3344
Device description
Diagnostic cardiac computerized reconfigurable stimulator system
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOQGenerator, Pulse, Pacemaker, External Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011826000EPS320 CARDIAC STIMULATORMicropace Pty, Ltd.2002-01-24JOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349714001028PackageGS11In Commercial Distribution
09349714003442PackageGS11In Commercial Distribution
09349714004562PackageGS11In Commercial Distribution
09349714004623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349714001028093497140010289349714001028
09349714003442093497140034429349714003442
09349714004562093497140045629349714004562
09349714004623093497140046239349714004623

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology stimulation systemAn assembly of devices programmed to deliver precisely timed electrical impulses to the heart, during spontaneous and paced rhythms, for diagnostic cardiac stimulation. It typically includes electrodes/leads applied to the heart and an external pulse generator (EPG). It may be used in asynchronous or synchronous mode, to deliver stimuli of variable strength, and for pacing in a wide range of cycle lengths (typically from 150 to 1500 ms). It is used for performing physiologic cardiac tests such as to determine the function of various components of the atrioventricular conduction, factors required for induction and termination of tachycardia, and to assess sinus node function.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+610297181746support@micropace.com.au

Regulatory Flags#

DUNS number
890719636
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349714010877MICROPACE PTY LIMITEDOneStimMP5003-4CO2026-07-21
09349714004630StimLabStimLabMP31722016-07-01
09349714011218OneLINK Splitter CableONELINKMP41102023-11-29
09349714004708MicropaceStimulus Generator UnitMP30082016-07-01
09349714004739ORLABORLAB MP31922016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDJOQ2026-07-21
05414734219136EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067002709EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067007865EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067007872EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067007889EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067051820EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
05415067051837EP-4™ST. JUDE MEDICAL, INC.JOQ2025-09-11
00863019000368Bloom2Fischer MedicalJOQ2021-02-23
00863019000337Bloom2Fischer MedicalJOQ2019-01-25
00863019000344Bloom2Fischer MedicalJOQ2019-01-25
00863019000351Bloom2Fischer MedicalJOQ2019-01-25
05414734030236EP-4™ST. JUDE MEDICAL, INC.JOQ2018-12-14
05415067018069WorkMate Claris™ST. JUDE MEDICAL, INC.JOQ2018-11-09
05415067018076WorkMate Claris™ST. JUDE MEDICAL, INC.JOQ2018-11-09
09349714004739ORLABMICROPACE PTY LIMITEDJOQ2016-09-23
00863019000306BloomFischer MedicalJOQ2016-09-12
00863019000313BloomFischer MedicalJOQ2016-09-12
00863019000320BloomFischer MedicalJOQ2016-09-12
09349714004630StimLabMICROPACE PTY LIMITEDJOQ2016-07-01
09349714004708MicropaceMICROPACE PTY LIMITEDJOQ2016-07-01
05414734219112EP-4™ST. JUDE MEDICAL, INC.JOQ2016-04-22
05414734208741EP-4™ST. JUDE MEDICAL, INC.JOQ2016-04-15
05414734208758EP-4™ST. JUDE MEDICAL, INC.JOQ2016-04-15