| Primary Device ID | 00860009303416 |
| NIH Device Record Key | 58df160a-07fd-41cb-859a-ae4a4396eed8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aventus Thrombectomy System - Clot Management System |
| Version Model Number | IM-0002 |
| Company DUNS | 117606791 |
| Company Name | Inquis 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 | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com | |
| Phone | 888-526-7738 |
| cs@inquismedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009303416 [Primary] |
| CAC | Apparatus, Autotransfusion |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
[00860009303416]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-31 |
| Device Publish Date | 2024-07-23 |
| 00860009303409 - Aventus Thrombectomy System - Aspiration Catheter | 2024-07-31 The Aventus Aspiration Catheter is a multi-lumen catheter with a flexible shaft and a tapered radiopaque tip designed to remove |
| 00860009303416 - Aventus Thrombectomy System - Clot Management System | 2024-07-31The Aventus Clot Management System is connected to the aspiration syringe and is used to filter and return blood to the patient as desired. The clot canister contains a coarse pre-filter to separate blood from clot and is designed to be compatible with off-the-shelf blood transfusion filters. |
| 00860009303416 - Aventus Thrombectomy System - Clot Management System | 2024-07-31 The Aventus Clot Management System is connected to the aspiration syringe and is used to filter and return blood to the patient |
| 00860005664009 - Isolaer Aerosol Isolation Barrier | 2021-02-11 The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during |