FDA.reportPublic FDA data

MICROPACE PTY LIMITED

Primary DI
09349714010877
Brand
MICROPACE PTY LIMITED
Company
MICROPACE PTY LIMITED
Model
OneStim
Catalog number
MP5003-4CO
Device description
OneStim-DUO Cardiac Stimulator
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253088000OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.2026-06-12DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349714012109PackageGS11In Commercial Distribution
09349714010877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349714012109093497140121099349714012109
09349714010877093497140108779349714010877

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
false
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
09349714004623EPS320EPS320 Cardiac StimulatorMP3102BT-GE-US, MP3102US2016-07-01
09349714004630StimLabStimLabMP31722016-07-01
09349714011218OneLINK Splitter CableONELINKMP41102023-11-29
09349714004708MicropaceStimulus Generator UnitMP30082016-07-01
09349714004739ORLABORLAB MP31922016-09-23

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Primary DI, Brand, Company table
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17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
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