| Primary Device ID | 00857042007456 |
| NIH Device Record Key | 0d15a4c6-71eb-4848-a9ae-3534f9e0c51b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcQGuide |
| Version Model Number | 122852 |
| Catalog Number | 122852 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857042007456 [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 | 2019-08-01 |
| Device Publish Date | 2019-07-24 |
| 00857042007012 | AcQGuide® Steerable Sheath |
| 00857042007456 | AcQGuide Flex 65 cm Med Curl with AcQCross QX |
| 00857042007432 | AcQGuide Mini 65cm - L2 with AcQCross QX |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACQGUIDE 87246283 5308281 Live/Registered |
Acutus Medical, Inc. 2016-11-23 |