AcQRef 900005
GUDID 00857042007142
AcQRef Introducer Sheath
ACUTUS MEDICAL, INC.
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.
| 00850027837253 - DiamondTemp Generator Adapter | 2024-11-15 AcQMap to DiamondTemp Generator Adapter |
| 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 |
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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