| Primary Device ID | 00850027837123 |
| NIH Device Record Key | 564d00cb-c191-430a-95ca-5aa5967cdd66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcQCross Qx |
| Version Model Number | 900303 |
| Catalog Number | 900303 |
| Company DUNS | 844418199 |
| Company Name | ACUTUS MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| Phone | (442)232-6100 |
| product.complaints@acutus.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850027837123 [Primary] |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-18 |
| Device Publish Date | 2021-10-08 |
| 00850027837161 | AcQCross Qx - MAX 70cm |
| 00850027837147 | AcQCross Qx - FC 65cm |
| 00850027837123 | AcQCross Qx - VZ 71cm |
| 00850027837109 | AcQCross Qx - SL 63cm |
| 00850027837086 | AcQCross Qx - AG 61cm |
| 00850027837055 | AcQCross Qx - AG 71cm |