AcQMap 800421
GUDID 00857042007241
AcQMap ECG Input Cable
ACUTUS MEDICAL, INC.
Cardiac mapping system| Primary Device ID | 00857042007241 |
| NIH Device Record Key | 5f8f4b5d-a3df-4347-af0b-5b8e5e7fcb56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcQMap |
| Version Model Number | 800421 |
| Catalog Number | 800421 |
| Company DUNS | 844418199 |
| Company Name | ACUTUS MEDICAL, INC. |
| 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 | false |
| Manufacturing Date | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857042007241 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190131
FDA Product Code
| DQK | Computer, Diagnostic, Programmable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-02 |
| Device Publish Date | 2019-07-25 |
On-Brand Devices [AcQMap]
| 00857042007135 | Ampere® Adapter Cable AcQMap®→ Ampere |
| 00857042007128 | AcQMap® Surface ECG Cable |
| 00857042007111 | AcQMap® Auxiliary Catheter Cable |
| 00857042007104 | AcQMap® Ablation Interface Unit Cable |
| 00857042007098 | AcQMap® Patient Interface Unit Cable |
| 00857042007081 | AcQMap® Patient Interface Unit |
| 00857042007074 | Ampere® Adapter Cable AcQMap® → Ablation Catheter |
| 00857042007067 | AcQMap® Ablation Interface Unit |
| 00857042007050 | AcQMap® Workstation |
| 00857042007043 | AcQMap® Console |
| 00857042007036 | AcQMap® Patient Electrode Kit |
| 00857042007029 | AcQMap® 3D Imaging & Mapping Catheter |
| 00857042007005 | North America Power Cord |
| 00857042007326 | AcQMap Ablation Reference Cable |
| 00857042007319 | AcQMap Ablation Electrogram Cable |
| 00857042007302 | AcQMap Auxiliary Interface Box |
| 00857042007296 | AcQMap Console |
| 00857042007289 | AcQMap Workstation |
| 00857042007272 | AcQMap 2mm Pin Jumper St |
| 00857042007265 | AcQMap ECG w/Snaps Cable |
| 00857042007258 | AcQMap ECG POST Cable |
| 00857042007241 | AcQMap ECG Input Cable |
| 00857042007234 | AcQMap ECG Output Cable |
| 00857042007418 | AcQMap Catheter Interface Cable |
| 00857042007401 | AcQMap 3D Imaging & Mapping Catheter |
| 00857042007920 | AcQMap System Console 2.0 |
| 00857042007562 | AcQMap Patient Electrode Kit |
| 00857042007999 | AcQMap System |
| 00857042007425 | AcQMap Auxiliary Interface Box, Console 2.0 |
| 00857042007388 | Cable, AcQMap Surface ECG Output (AHA) Packaged |
| 00857042007364 | POAG Cable MC-POAG-EC6/2 |
| 00857042007357 | Workstation Cable |
| 00857042007333 | Power Cord, Console 2.0 |
| 00850027837482 | Maestro Adapter Cable, AcQMap to Catheter |
| 00850027837475 | Maestro Adapter Cable, AcQMap to Generator |
| 00850027837468 | Adapter Cable-Long, Ablation Adapter to AcQMap |
| 00850027837451 | Adapter Cable-Short, Ablation Adapter to AcQMap |
| 00850027837444 | Carto Force Adapter Cable Shipping Assembly |
| 00850027837246 | AcQMap to Maestro Generator Adapter |
| 00850027837239 | AcQMap to SmartAblate Generator Adapter |
| 00850027837222 | AcQMap to SmartAblate Generator Adapter |
| 00850027837192 | SmartAblate™ Adapter Cable AcQMap to Catheter |
Trademark Results [AcQMap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACQMAP 86369370 5171929 Live/Registered |
Acutus Medical, Inc. 2014-08-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.