| Primary Device ID | 00857042007906 |
| NIH Device Record Key | 4b85e5c9-f0a4-41cf-ba5d-573104d7c98f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcQGuide VUE |
| Version Model Number | 900201 |
| Catalog Number | 900201 |
| 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 | 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 |
| Phone | (442)232-6100 |
| product.complaints@acutus.com | |
| Phone | (442)232-6100 |
| product.complaints@acutus.com | |
| Phone | (442)232-6100 |
| product.complaints@acutus.com | |
| Phone | (442)232-6100 |
| product.complaints@acutus.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857042007906 [Primary] |
| DRA | Catheter, Steerable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-23 |
| Device Publish Date | 2022-05-13 |
| 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 |