| Primary Device ID | 00850027837017 |
| NIH Device Record Key | 1c99937e-d8b4-4141-9134-c321d067af5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcQGuide MAX |
| Version Model Number | 900200 |
| Catalog Number | 900200 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850027837017 [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 | 2021-10-18 |
| Device Publish Date | 2021-10-08 |
| 00850027837017 | 12F AcQGuide MAX 2.0 Steerable Sheath |
| 00850027837666 | 12F AcQGuide MAX 2.0 Steerable Sheath |