AcQRef 900005
GUDID 00857042007142
AcQRef Introducer Sheath
ACUTUS MEDICAL, INC.
Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable| Primary Device ID | 00857042007142 |
| NIH Device Record Key | eee8ef6b-d771-42f1-9738-1855e87e8121 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcQRef |
| Version Model Number | 900005 |
| Catalog Number | 900005 |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857042007142 [Primary] |
FDA Product Code
| DYB | Introducer, Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-25 |
| Device Publish Date | 2021-10-15 |
Devices Manufactured by ACUTUS MEDICAL, INC.
| 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 |
| 00850027837840 - FlexCath Cross Transseptal Solution | 2023-09-11 FlexCath Cross Transseptal Solution– MAX 70 cm |
Trademark Results [AcQRef]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACQREF 87392334 5454869 Live/Registered |
Acutus Medical, Inc. 2017-03-30 |
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