FDA.reportPublic FDA data

StimLab

Primary DI
09349714004630
Brand
StimLab
Company
MICROPACE PTY LIMITED
Model
StimLab
Catalog number
MP3172
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

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
K072200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072200000STIMLABMicropace Pty, Ltd.2007-10-26JOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349714004630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349714004630093497140046309349714004630

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 Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
890719636
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349714011218OneLINK Splitter CableONELINKMP41102023-11-29
09349714004708MicropaceStimulus Generator UnitMP30082016-07-01
09349714004739ORLABORLAB MP31922016-09-23
09349714004623MicropaceEPS320_StimCor CardiacStimulatorMP3102BT-GE-US, MP3102US, MP33442016-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09349714004623MicropaceMICROPACE 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