AcQMap® 800365-003
GUDID 00857042007210
Patient Electrode Kit 900100
ACUTUS MEDICAL, INC.
Cardiac mapping system reference patch| Primary Device ID | 00857042007210 |
| NIH Device Record Key | 52504b59-0c69-4f9c-b7b8-bc2a04622426 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcQMap® |
| Version Model Number | 800365-003 |
| Catalog Number | 800365-003 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00857042007210 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190131
FDA Product Code
| DRX | Electrode, Electrocardiograph |
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 | 2019-07-23 |
| Device Publish Date | 2019-07-15 |
Devices Manufactured by ACUTUS MEDICAL, INC.
| 00850027837253 - DiamondTemp Generator Adapter | 2024-11-15 AcQMap to DiamondTemp Generator Adapter |
| 00850027837970 - FlexCath Cross Transseptal Solution | 2023-12-28 |
| 00850027837994 - FlexCath Cross Transseptal Solution | 2023-12-28 |
| 00850027837741 - FlexCath Cross Transseptal Solution | 2023-09-11 FlexCath Cross Transseptal Solution– AG 61 cm |
| 00850027837765 - FlexCath Cross Transseptal Solution | 2023-09-11 FlexCath Cross Transseptal Solution– AG 71 cm |
| 00850027837789 - FlexCath Cross Transseptal Solution | 2023-09-11 FlexCath Cross Transseptal Solution– SL 63 cm |
| 00850027837802 - FlexCath Cross Transseptal Solution | 2023-09-11 FlexCath Cross Transseptal Solution– VZ 71 cm |
| 00850027837826 - FlexCath Cross Transseptal Solution | 2023-09-11 FlexCath Cross Transseptal Solution– FC 65 cm |
Trademark Results [AcQMap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACQMAP 86369370 5171929 Live/Registered |
Acutus Medical, Inc. 2014-08-18 |
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