Micropace
GUDID 09349714004623
Diagnostic cardiac computerized reconfigurable stimulator system
MICROPACE PTY LIMITED
Cardiac electrophysiology stimulation system| Primary Device ID | 09349714004623 |
| NIH Device Record Key | f819e8b8-bb4b-485c-a3da-ceefe2b67ed5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micropace |
| Version Model Number | EPS320_StimCor CardiacStimulator |
| Company DUNS | 890719636 |
| Company Name | MICROPACE PTY LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09349714004623 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K011826
FDA Product Code
| JOQ | Generator, Pulse, Pacemaker, External Programmable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-12-15 |
| Device Publish Date | 2016-07-01 |
On-Brand Devices [Micropace]
| 09349714004739 | Diagnostic cardiac computerized reconfigurable stimulator system |
| 09349714004708 | Replacement Stimulus Generator Unit for EPS320 Family of Cardiac Stimulator Reconfigurable syste |
| 09349714004630 | Diagnostic cardiac computerized reconfigurable stimulator system |
| 09349714004623 | Diagnostic cardiac computerized reconfigurable stimulator system |
Trademark Results [Micropace]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROPACE 79163515 4815447 Live/Registered |
Micropace Pty Ltd 2014-09-09 |
 MICROPACE 78778038 not registered Dead/Abandoned |
Magnitude Information Systems, Inc. 2005-12-21 |
 MICROPACE 76378518 not registered Dead/Abandoned |
Magnitude Information Systems, Inc. 2002-03-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.